Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide (NCT NCT03185819)
NCT ID: NCT03185819
Last Updated: 2025-04-29
Results Overview
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)
Results posted on
2025-04-29
Participant Flow
A total of 147 participants were randomized and treated. One participant (randomized to arm "Esketamine 84 mg+Placebo+standard of care \[SOC\]") was excluded from the efficacy analysis set, safety analysis set, and follow-up analysis set due to Good Clinical Practice (GCP) issue at the site.
Adolescent participants with major depressive disorder (MDD) who were assessed to be at imminent risk for suicide were enrolled in this study.
Participant milestones
| Measure |
Placebo + Midazolam + SOC
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment follow-up (FU) phase and received no study drug.
|
Esketamine 28 mg + Placebo + SOC
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 56 mg + Placebo + SOC
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 84 mg + Placebo + SOC
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at 0, 5 and 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
|---|---|---|---|---|
|
Double-Blind Phase: Day 1 to Day 25
STARTED
|
63
|
29
|
31
|
24
|
|
Double-Blind Phase: Day 1 to Day 25
Safety Analysis Set
|
63
|
29
|
31
|
23
|
|
Double-Blind Phase: Day 1 to Day 25
Full Efficacy Analysis Set
|
63
|
28
|
31
|
23
|
|
Double-Blind Phase: Day 1 to Day 25
Follow-up Analysis Set
|
59
|
29
|
29
|
21
|
|
Double-Blind Phase: Day 1 to Day 25
COMPLETED
|
59
|
29
|
29
|
22
|
|
Double-Blind Phase: Day 1 to Day 25
NOT COMPLETED
|
4
|
0
|
2
|
2
|
|
Post-treatment Follow-up: Days 26 to 200
STARTED
|
59
|
29
|
29
|
21
|
|
Post-treatment Follow-up: Days 26 to 200
COMPLETED
|
48
|
24
|
21
|
18
|
|
Post-treatment Follow-up: Days 26 to 200
NOT COMPLETED
|
11
|
5
|
8
|
3
|
Reasons for withdrawal
| Measure |
Placebo + Midazolam + SOC
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment follow-up (FU) phase and received no study drug.
|
Esketamine 28 mg + Placebo + SOC
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 56 mg + Placebo + SOC
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 84 mg + Placebo + SOC
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at 0, 5 and 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
|---|---|---|---|---|
|
Double-Blind Phase: Day 1 to Day 25
Withdrawal by parent/guardian
|
0
|
0
|
0
|
1
|
|
Double-Blind Phase: Day 1 to Day 25
Other
|
1
|
0
|
1
|
0
|
|
Double-Blind Phase: Day 1 to Day 25
Adverse Event
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase: Day 1 to Day 25
Lack of Efficacy
|
2
|
0
|
1
|
0
|
|
Double-Blind Phase: Day 1 to Day 25
Subject refused further study treatment
|
0
|
0
|
0
|
1
|
|
Post-treatment Follow-up: Days 26 to 200
Withdrawal by parent/guardian
|
1
|
0
|
1
|
0
|
|
Post-treatment Follow-up: Days 26 to 200
Other
|
1
|
0
|
3
|
1
|
|
Post-treatment Follow-up: Days 26 to 200
Adverse Event
|
0
|
1
|
0
|
0
|
|
Post-treatment Follow-up: Days 26 to 200
Requires treatment with electroconvulsive therapy, transcranial magnetic stimulation, ketamine
|
1
|
0
|
0
|
0
|
|
Post-treatment Follow-up: Days 26 to 200
Withdrawal by Subject
|
3
|
3
|
2
|
0
|
|
Post-treatment Follow-up: Days 26 to 200
Physician Decision
|
2
|
0
|
2
|
0
|
|
Post-treatment Follow-up: Days 26 to 200
Lost to Follow-up
|
2
|
1
|
0
|
2
|
|
Post-treatment Follow-up: Days 26 to 200
Death
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
Baseline characteristics by cohort
| Measure |
Placebo + Midazolam + SOC
n=63 Participants
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment follow-up (FU) phase and received no study drug.
|
Esketamine 28 mg + Placebo + SOC
n=29 Participants
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 56 mg + Placebo + SOC
n=31 Participants
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 84 mg + Placebo + SOC
n=23 Participants
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at 0, 5 and 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 1.45 • n=39 Participants
|
14.9 years
STANDARD_DEVIATION 1.33 • n=41 Participants
|
14.8 years
STANDARD_DEVIATION 1.52 • n=35 Participants
|
14.3 years
STANDARD_DEVIATION 1.43 • n=31 Participants
|
14.9 years
STANDARD_DEVIATION 1.46 • n=146 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
63 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
146 Participants
n=146 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Customized
From 65 to 84 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
114 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
104 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
118 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)Population: Full efficacy analysis set for DB phase included all randomized participants who received at least 1 dose of DB study medication during the DB phase and had both baseline \& post dose evaluation for CDRS-R total score. As pre-planned in study statistical analysis plan (SAP), data were planned to be collected and analyzed on pooled population who had received esketamine (56 mg/84 mg) in arms "Esketamine 56 mg + Placebo + SOC" and "Esketamine 84 mg + Placebo + SOC" respectively.
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Outcome measures
| Measure |
Placebo + Midazolam + SOC
n=63 Participants
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment follow-up (FU) phase and received no study drug.
|
Esketamine 28 mg + Placebo + SOC
n=28 Participants
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 56 mg + Placebo + SOC
n=31 Participants
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Esketamine 84 mg + Placebo + SOC
n=23 Participants
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at 0, 5 and 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
Pooled Esketamine 56 mg + Esketamine 84 mg
n=54 Participants
All participants who received intranasal doses of esketamine 56 mg nasal spray (2 doses in each nostril, 14 mg per spray + 1 dose of matched placebo nasal spray) and esketamine 84 mg nasal spray (3 doses in each nostril, 14 mg per spray) along with placebo matched to midazolam oral solution times per week for 4 weeks (i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25).
|
|---|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)
|
-26.2 Units on a scale
Standard Deviation 16.72
|
-29.6 Units on a scale
Standard Deviation 18.15
|
-31.8 Units on a scale
Standard Deviation 12.92
|
-30.3 Units on a scale
Standard Deviation 17.48
|
-31.2 Units on a scale
Standard Deviation 14.90
|
Adverse Events
DB: Placebo + Midazolam + SOC
Serious events: 9 serious events
Other events: 57 other events
Deaths: 0 deaths
DB: Esketamine 28 mg + Placebo + SOC
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
DB: Esketamine 56 mg + Placebo + SOC
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
DB: Esketamine 84 mg + Placebo + SOC
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
FU Phase: Placebo + Midazolam + SOC
Serious events: 19 serious events
Other events: 48 other events
Deaths: 1 deaths
FU Phase: Esketamine 28 mg + Placebo + SOC
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
FU Phase: Esketamine 56 mg + Placebo + SOC
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
FU Phase: Esketamine 84 mg + Placebo + SOC
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB: Placebo + Midazolam + SOC
n=63 participants at risk
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 28 mg + Placebo + SOC
n=29 participants at risk
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 56 mg + Placebo + SOC
n=31 participants at risk
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC:antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 84 mg + Placebo + SOC
n=23 participants at risk
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at time points 0, 5 and 10 minutes respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC:antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
FU Phase: Placebo + Midazolam + SOC
n=59 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
FU Phase: Esketamine 28 mg + Placebo + SOC
n=29 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
FU Phase: Esketamine 56 mg + Placebo + SOC
n=29 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.).
|
FU Phase: Esketamine 84 mg + Placebo + SOC
n=21 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Status Migrainosus
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Infections and infestations
HIV Infection
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Metabolism and nutrition disorders
Food Refusal
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Depression Suicidal
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Suicidal Ideation
|
4.8%
3/63 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.8%
4/59 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
17.2%
5/29 • Number of events 10 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
14.3%
3/21 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Suicide Attempt
|
7.9%
5/63 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
16.1%
5/31 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
15.3%
9/59 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
17.2%
5/29 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
19.0%
4/21 • Number of events 8 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
Other adverse events
| Measure |
DB: Placebo + Midazolam + SOC
n=63 participants at risk
In the double blind (DB) phase, participants received 3 intranasal doses of placebo (matched to esketamine nasal spray) using 3 devces, each device at time points 0, 5 and 10 minutes (min) respectively. For each device, 1 spray was administered into each nostril (that is total of 2 sprays/device). An oral solution of midazolam 0.125 milligrams per kilogram (mg/kg) was administered immediately before the first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During the study, all participants were treated with Standard of care (SOC): antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated, or optimized on Day 1 or up to 7 days after first dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB treatment phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 28 mg + Placebo + SOC
n=29 participants at risk
In DB phase, participants received 1 intranasal dose of esketamine 28 mg nasal spray using a device, at 0 min, followed by 2 intranasal doses of placebo (matched to esketamine) using 2 devices, 1 at 5 min and another at 10 min, respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC: antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 56 mg + Placebo + SOC
n=31 participants at risk
In DB phase, participants received 2 intranasal doses of esketamine 56 mg nasal spray using 2 devices, 1 at 0 min and another at 5 min, followed by 1 intranasal dose of placebo (matched to esketamine) using 1 device at 10 min. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC:antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
DB: Esketamine 84 mg + Placebo + SOC
n=23 participants at risk
In DB phase, participants received 3 intranasal doses of esketamine 84 mg nasal spray using 3 devices, each device at time points 0, 5 and 10 minutes respectively. For each device, 1 spray (esketamine 14 mg/placebo) was administered into each nostril (that is total of 2 sprays = esketamine 28 mg/placebo). Placebo oral solution (matched to midazolam 0.125 mg/kg) was administered immediately before first intranasal dose. Study drugs were taken 2 times per week for 4 weeks (on Days 1, 4, 8, 11, 15, 18, 22, and 25). During study, all participants received SOC:antidepressant treatment (fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after first dose (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy. After DB phase, participants entered post-treatment FU phase and received no study drug.
|
FU Phase: Placebo + Midazolam + SOC
n=59 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
FU Phase: Esketamine 28 mg + Placebo + SOC
n=29 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
FU Phase: Esketamine 56 mg + Placebo + SOC
n=29 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.).
|
FU Phase: Esketamine 84 mg + Placebo + SOC
n=21 participants at risk
After completion of DB treatment phase, participants entered post-treatment follow-up phase and received no study drug. During the study, all participants were treated with SOC: antidepressant treatment (either fluoxetine or escitalopram or sertaline) based on clinical judgement, initiated or optimized on Day 1 or up to 7 days after 1st dose of study drug administration (on Day 1), if starting two medications simultaneously was not consistent with local clinical practice, and psychotherapy.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
2/63 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.7%
3/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.7%
8/63 • Number of events 8 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Eye disorders
Vision Blurred
|
1.6%
1/63 • Number of events 8 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
12.9%
4/31 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.0%
3/23 • Number of events 12 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.3%
4/63 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.0%
3/23 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
11.9%
7/59 • Number of events 8 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/63 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.2%
6/59 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
20.7%
6/29 • Number of events 19 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
19.4%
6/31 • Number of events 29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
21.7%
5/23 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
11/63 • Number of events 13 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
27.6%
8/29 • Number of events 19 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
48.4%
15/31 • Number of events 43 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
56.5%
13/23 • Number of events 37 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
15.3%
9/59 • Number of events 10 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
4/63 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
17.2%
5/29 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
22.6%
7/31 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
26.1%
6/23 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.8%
4/59 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
General disorders
Fatigue
|
4.8%
3/63 • Number of events 9 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
General disorders
Feeling Drunk
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
General disorders
Pyrexia
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Infections and infestations
Covid-19
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Infections and infestations
Influenza
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Investigations
Weight Increased
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.5%
5/59 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
12.9%
4/31 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.8%
4/59 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Dizziness
|
42.9%
27/63 • Number of events 44 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
55.2%
16/29 • Number of events 76 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
51.6%
16/31 • Number of events 88 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
69.6%
16/23 • Number of events 58 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Dysgeusia
|
23.8%
15/63 • Number of events 53 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
34.5%
10/29 • Number of events 57 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
25.8%
8/31 • Number of events 33 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
39.1%
9/23 • Number of events 39 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Headache
|
28.6%
18/63 • Number of events 33 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
34.5%
10/29 • Number of events 17 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
41.9%
13/31 • Number of events 34 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
30.4%
7/23 • Number of events 18 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
20.3%
12/59 • Number of events 20 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
34.5%
10/29 • Number of events 14 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
24.1%
7/29 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
14.3%
3/21 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Hypoaesthesia
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
17.2%
5/29 • Number of events 12 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
25.8%
8/31 • Number of events 24 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
17.4%
4/23 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Memory Impairment
|
6.3%
4/63 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.7%
3/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Paraesthesia
|
1.6%
1/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.7%
3/31 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Sedation
|
14.3%
9/63 • Number of events 45 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
12.9%
4/31 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Somnolence
|
38.1%
24/63 • Number of events 123 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
34.5%
10/29 • Number of events 36 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
29.0%
9/31 • Number of events 34 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
34.8%
8/23 • Number of events 25 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Syncope
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Nervous system disorders
Tremor
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
5.1%
3/59 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Agitation
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Anxiety
|
15.9%
10/63 • Number of events 15 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
12.9%
4/31 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
11.9%
7/59 • Number of events 16 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.8%
4/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
14.3%
3/21 • Number of events 11 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Confusional State
|
6.3%
4/63 • Number of events 12 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Depression
|
3.2%
2/63 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
19.0%
4/21 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 8 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Dissociation
|
17.5%
11/63 • Number of events 24 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
41.4%
12/29 • Number of events 46 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
38.7%
12/31 • Number of events 51 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
47.8%
11/23 • Number of events 58 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Euphoric Mood
|
9.5%
6/63 • Number of events 12 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
20.7%
6/29 • Number of events 17 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
16.1%
5/31 • Number of events 22 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
21.7%
5/23 • Number of events 24 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Hallucination, Visual
|
4.8%
3/63 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Illusion
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Initial Insomnia
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Insomnia
|
12.7%
8/63 • Number of events 16 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.8%
4/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.8%
4/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Intentional Self-Injury
|
19.0%
12/63 • Number of events 19 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
20.7%
6/29 • Number of events 9 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
19.4%
6/31 • Number of events 12 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
21.7%
5/23 • Number of events 7 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
35.6%
21/59 • Number of events 33 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
24.1%
7/29 • Number of events 19 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
10.3%
3/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
33.3%
7/21 • Number of events 17 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.2%
2/63 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.8%
4/59 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.5%
2/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Psychiatric disorders
Time Perception Altered
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Renal and urinary disorders
Dysuria
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.8%
3/63 • Number of events 6 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.8%
4/59 • Number of events 9 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.8%
3/63 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
3.2%
2/63 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.7%
3/31 • Number of events 5 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
13.0%
3/23 • Number of events 9 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.8%
3/63 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
2/59 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.8%
1/21 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Hypoaesthesia
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.6%
1/63 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.2%
1/31 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
4.8%
3/63 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 4 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
9.7%
3/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
8.7%
2/23 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 3 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
4.3%
1/23 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/63 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.9%
2/29 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/31 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
1.7%
1/59 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
|
Vascular disorders
Hypotension
|
6.3%
4/63 • Number of events 9 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
3.4%
1/29 • Number of events 1 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
6.5%
2/31 • Number of events 2 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/23 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/59 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/29 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
|
0.00%
0/21 • Double Blind treatment phase: From Day 1 to Day 25; Follow-up phase: From Day 26 up to end of post-treatment follow-up phase (Day 200)
Safety analysis set for DB treatment phase included all randomized participants who received at least 1 dose of study medication during the DB treatment phase. Follow-up analysis set for follow-up phase included all participants who completed the DB treatment phase and either entered the follow-up phase or had provided AE data after the DB treatment phase.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER