Trial Outcomes & Findings for A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia (NCT NCT04072354)
NCT ID: NCT04072354
Last Updated: 2026-05-28
Results Overview
PANSS was an interview-based assessment comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). The Positive subscale assessed hallucinations, delusions, and related symptoms; the Negative subscale assessed emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addressed other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicated the presence of progressively more severe symptoms, was used to score each item. Individual items were then summed to determine scores for the 3 subscales, as well as a total score. PANSS total score ranges from: 30-210, where a higher score indicates greater severity. A negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2026-05-28
Participant Flow
Participants took part in the study at investigational sites in the United States, Russia, Ukraine, Bulgaria, and Serbia from 17 September 2019 to 12 September 2023.
A total of 628 participants were screened, of which 463 participants (435 adults and 28 adolescents) were randomized to receive SEP-363856 50mg, 75 mg or placebo.
Participant milestones
| Measure |
Adults: Placebo
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
Participants received SEP-363856 50 milligrams (mg) tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 75mg
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adolescents: Placebo
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 50mg
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 75 mg
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
146
|
144
|
145
|
10
|
9
|
9
|
|
Overall Study
COMPLETED
|
119
|
110
|
118
|
10
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
27
|
34
|
27
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Adults: Placebo
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
Participants received SEP-363856 50 milligrams (mg) tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 75mg
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adolescents: Placebo
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 50mg
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 75 mg
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
18
|
11
|
0
|
0
|
0
|
|
Overall Study
COVID-19 Related Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
5
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
10
|
0
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Covid-19 Related
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Baseline characteristics by cohort
| Measure |
Adults: Placebo
n=146 Participants
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
n=144 Participants
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 75mg
n=145 Participants
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adolescents: Placebo
n=10 Participants
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 50mg
n=9 Participants
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 75mg
n=9 Participants
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.33 • n=51 Participants
|
36.1 years
STANDARD_DEVIATION 9.38 • n=14 Participants
|
37.0 years
STANDARD_DEVIATION 10.23 • n=65 Participants
|
15.5 years
STANDARD_DEVIATION 1.43 • n=24 Participants
|
14.8 years
STANDARD_DEVIATION 1.39 • n=107 Participants
|
15.0 years
STANDARD_DEVIATION 1.41 • n=1000 Participants
|
35.0 years
STANDARD_DEVIATION 10.92
|
|
Sex: Female, Male
Female
|
73 Participants
n=51 Participants
|
46 Participants
n=14 Participants
|
59 Participants
n=65 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=1000 Participants
|
190 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=51 Participants
|
98 Participants
n=14 Participants
|
86 Participants
n=65 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=1000 Participants
|
273 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=51 Participants
|
139 Participants
n=14 Participants
|
142 Participants
n=65 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=1000 Participants
|
451 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=51 Participants
|
30 Participants
n=14 Participants
|
33 Participants
n=65 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=1000 Participants
|
109 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=51 Participants
|
113 Participants
n=14 Participants
|
111 Participants
n=65 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=1000 Participants
|
346 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=1000 Participants
|
2 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=51 Participants
|
40 participants
n=14 Participants
|
39 participants
n=65 Participants
|
7 participants
n=24 Participants
|
7 participants
n=107 Participants
|
7 participants
n=1000 Participants
|
140 participants
|
|
Region of Enrollment
Ukraine
|
26 participants
n=51 Participants
|
26 participants
n=14 Participants
|
26 participants
n=65 Participants
|
0 participants
n=24 Participants
|
0 participants
n=107 Participants
|
0 participants
n=1000 Participants
|
78 participants
|
|
Region of Enrollment
Bulgaria
|
18 participants
n=51 Participants
|
18 participants
n=14 Participants
|
18 participants
n=65 Participants
|
0 participants
n=24 Participants
|
0 participants
n=107 Participants
|
0 participants
n=1000 Participants
|
54 participants
|
|
Region of Enrollment
Serbia
|
43 participants
n=51 Participants
|
42 participants
n=14 Participants
|
44 participants
n=65 Participants
|
3 participants
n=24 Participants
|
2 participants
n=107 Participants
|
2 participants
n=1000 Participants
|
136 participants
|
|
Region of Enrollment
Russia
|
19 participants
n=51 Participants
|
18 participants
n=14 Participants
|
18 participants
n=65 Participants
|
0 participants
n=24 Participants
|
0 participants
n=107 Participants
|
0 participants
n=1000 Participants
|
55 participants
|
|
PANSS Total Score
|
101.9 units on a scale
STANDARD_DEVIATION 10.56 • n=51 Participants
|
102.3 units on a scale
STANDARD_DEVIATION 10.02 • n=14 Participants
|
101.7 units on a scale
STANDARD_DEVIATION 10.09 • n=65 Participants
|
96.0 units on a scale
STANDARD_DEVIATION 10.51 • n=24 Participants
|
104.6 units on a scale
STANDARD_DEVIATION 14.57 • n=107 Participants
|
97.9 units on a scale
STANDARD_DEVIATION 8.16 • n=1000 Participants
|
101.8 units on a scale
STANDARD_DEVIATION 10.29
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: The mITT population included all randomized participant that received at least 1 dose of study drug, and had a baseline and at least 1 post-baseline efficacy measurement in PANSS or CGI-S. This outcome measure was only assessed in Adult population. Here overall number analyzed are the participants with data available at specified timepoint.
PANSS was an interview-based assessment comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). The Positive subscale assessed hallucinations, delusions, and related symptoms; the Negative subscale assessed emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addressed other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicated the presence of progressively more severe symptoms, was used to score each item. Individual items were then summed to determine scores for the 3 subscales, as well as a total score. PANSS total score ranges from: 30-210, where a higher score indicates greater severity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Adults: SEP-363856 75mg
n=145 Participants
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adults: Placebo
n=145 Participants
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
n=142 Participants
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
|---|---|---|---|
|
Change From Baseline in PANSS Total Score at Week 6
|
-19.6 score on a scale
Standard Error 1.56
|
-19.3 score on a scale
Standard Error 1.55
|
-16.9 score on a scale
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: The mITT population included all randomized participants that received at least 1 dose of study drug, and had a baseline and at least 1 post-baseline efficacy measurement in PANSS or CGI-S. This outcome measure was only assessed in Adult population. Here overall number analyzed are the participants with data available at specified timepoint.
The CGI-S was a single-item clinician-rated assessment of the participant's current illness state on a 7-point scale (score range: 1-7), where a higher score was associated with greater illness severity.
Outcome measures
| Measure |
Adults: SEP-363856 75mg
n=145 Participants
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adults: Placebo
n=145 Participants
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
n=142 Participants
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
|---|---|---|---|
|
Change From Baseline in CGI-S Total Score at Week 6
|
-1.01 score on a scale
Standard Error 0.086
|
-0.90 score on a scale
Standard Error 0.085
|
-0.80 score on a scale
Standard Error 0.086
|
Adverse Events
Adults: Placebo
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Adults: SEP-363856 50mg
Serious events: 11 serious events
Other events: 55 other events
Deaths: 0 deaths
Adults: SEP-363856 75mg
Serious events: 12 serious events
Other events: 50 other events
Deaths: 0 deaths
Adolescents: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adolescents: SEP-363856 50mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Adolescents: SEP-363856 75mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adults: Placebo
n=146 participants at risk
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
n=144 participants at risk
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 75mg
n=145 participants at risk
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adolescents: Placebo
n=10 participants at risk
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 50mg
n=9 participants at risk
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 75mg
n=9 participants at risk
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
General disorders
Drug ineffective
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.69%
1/144 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Psychiatric disorders
Schizophrenia
|
2.1%
3/146 • Number of events 3 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
6.9%
10/144 • Number of events 10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
8.3%
12/145 • Number of events 12 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Infections and infestations
Corona virus infection
|
0.68%
1/146 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
Other adverse events
| Measure |
Adults: Placebo
n=146 participants at risk
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 50mg
n=144 participants at risk
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adults: SEP-363856 75mg
n=145 participants at risk
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
Adolescents: Placebo
n=10 participants at risk
Participants received matched SEP-363856 placebo tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 50mg
n=9 participants at risk
Participants received SEP-363856 50 mg tablet, orally, once daily up to Week 6.
|
Adolescents: SEP-363856 75mg
n=9 participants at risk
Participants received SEP-363856 tablet, orally, once daily at a starting dose of 50 mg on Day 1 through Day 3 followed by dose-escalation to 75 mg from Day 4 up to Week 6.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
2.7%
4/146 • Number of events 4 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
16/144 • Number of events 17 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
9.0%
13/145 • Number of events 15 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
4.8%
7/146 • Number of events 7 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
5.6%
8/144 • Number of events 12 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
7.6%
11/145 • Number of events 17 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.2%
9/146 • Number of events 10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.8%
17/144 • Number of events 18 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.7%
17/145 • Number of events 19 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
11/146 • Number of events 11 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
8.3%
12/144 • Number of events 13 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
6.9%
10/145 • Number of events 10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/146 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/144 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/145 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
4.8%
7/146 • Number of events 8 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
7.6%
11/144 • Number of events 13 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
7.6%
11/145 • Number of events 13 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.5%
11/146 • Number of events 15 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
11.1%
16/144 • Number of events 21 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
6.2%
9/145 • Number of events 12 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/10 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
0.00%
0/9 • From the first dose of study drug up to 7 days after the last dose of the study drug (up to approximately 7 weeks)
Safety population included all randomized participants that received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place