Trial Outcomes & Findings for RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (NCT NCT01490086)
NCT ID: NCT01490086
Last Updated: 2025-08-08
Results Overview
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2025-08-08
Participant Flow
270 Subjects with acute exacerbation Schizophrenia and Schizoaffective disorder were selected from multiple sites in USA, Moldova, India, Philippines and Malaysia between December 2011 and January 2013.
Subjects were screened over a period of 7 days in the site's in-patient facility. 270 subjects were recruited. Of these, 36 subjects did not meet the study eligibility criteria. Therefore, a total of 234 subjects were enrolled into the study.
Participant milestones
| Measure |
RP5063 15 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
58
|
20
|
39
|
|
Overall Study
COMPLETED
|
50
|
44
|
51
|
13
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
7
|
7
|
11
|
Reasons for withdrawal
| Measure |
RP5063 15 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
Consent withdrawn
|
4
|
4
|
3
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Abnormal laboratory findings
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
4
|
2
|
3
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
1
|
0
|
8
|
|
Overall Study
Worsening of symptoms
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Subject uncontrollable and abusive
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject left hospital
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
RP5063 15 mg
n=58 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=59 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=58 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=20 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=38 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 10 • n=5 Participants
|
37 years
STANDARD_DEVIATION 12 • n=7 Participants
|
35 years
STANDARD_DEVIATION 9 • n=5 Participants
|
35 years
STANDARD_DEVIATION 10 • n=4 Participants
|
36 years
STANDARD_DEVIATION 12 • n=21 Participants
|
36 years
STANDARD_DEVIATION 11 • n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
178 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
232 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
208 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=10 Participants
|
|
Region of Enrollment
Philippines
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
5 participants
n=4 Participants
|
9 participants
n=21 Participants
|
59 participants
n=10 Participants
|
|
Region of Enrollment
Malaysia
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
42 participants
n=10 Participants
|
|
Region of Enrollment
Moldova, Republic of
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=10 Participants
|
|
Region of Enrollment
India
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
10 participants
n=4 Participants
|
17 participants
n=21 Participants
|
108 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.
Outcome measures
| Measure |
RP5063 15 mg
n=56 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=19 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=37 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline
|
87.57 scores on a scale
Standard Deviation 13.30
|
88.74 scores on a scale
Standard Deviation 13.37
|
85.88 scores on a scale
Standard Deviation 14.86
|
91.68 scores on a scale
Standard Deviation 16.10
|
89.84 scores on a scale
Standard Deviation 15.60
|
|
Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
Day 28
|
67.34 scores on a scale
Standard Deviation 21.98
|
73.32 scores on a scale
Standard Deviation 20.24
|
66.67 scores on a scale
Standard Deviation 19.66
|
82.37 scores on a scale
Standard Deviation 22.13
|
78.43 scores on a scale
Standard Deviation 24.14
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.
Outcome measures
| Measure |
RP5063 15 mg
n=56 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=19 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=37 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
Baseline
|
4.79 scores on a scale
Standard Deviation 0.56
|
4.81 scores on a scale
Standard Deviation 0.77
|
4.75 scores on a scale
Standard Deviation 0.71
|
4.84 scores on a scale
Standard Deviation 0.60
|
4.76 scores on a scale
Standard Deviation 0.55
|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
Day 28
|
3.48 scores on a scale
Standard Deviation 1.22
|
3.93 scores on a scale
Standard Deviation 1.24
|
3.54 scores on a scale
Standard Deviation 1.05
|
4.53 scores on a scale
Standard Deviation 1.02
|
4.05 scores on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Outcome measures
| Measure |
RP5063 15 mg
n=56 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=19 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=37 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
Baseline
|
24.79 scores on a scale
Standard Deviation 4.21
|
23.77 scores on a scale
Standard Deviation 4.66
|
23.68 scores on a scale
Standard Deviation 4.73
|
25.42 scores on a scale
Standard Deviation 6.77
|
24.54 scores on a scale
Standard Deviation 3.78
|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
Day 28
|
17.82 scores on a scale
Standard Deviation 7.95
|
18.75 scores on a scale
Standard Deviation 7.27
|
16.72 scores on a scale
Standard Deviation 6.66
|
23.47 scores on a scale
Standard Deviation 7.88
|
19.95 scores on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Outcome measures
| Measure |
RP5063 15 mg
n=56 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=19 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=37 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
Day 28
|
16.96 scores on a scale
Standard Deviation 5.11
|
19.21 scores on a scale
Standard Deviation 5.92
|
17.72 scores on a scale
Standard Deviation 5.89
|
19.47 scores on a scale
Standard Deviation 5.16
|
20.57 scores on a scale
Standard Deviation 6.64
|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
Baseline
|
21.80 scores on a scale
Standard Deviation 5.63
|
22.89 scores on a scale
Standard Deviation 5.25
|
21.37 scores on a scale
Standard Deviation 5.91
|
22.53 scores on a scale
Standard Deviation 4.38
|
22.24 scores on a scale
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Outcome measures
| Measure |
RP5063 15 mg
n=56 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=57 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=19 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=37 Participants
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
Baseline
|
40.98 scores on a scale
Standard Deviation 7.30
|
42.07 scores on a scale
Standard Deviation 7.08
|
40.82 scores on a scale
Standard Deviation 7.61
|
43.74 scores on a scale
Standard Deviation 9.41
|
43.05 scores on a scale
Standard Deviation 8.36
|
|
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
Day 28
|
32.55 scores on a scale
Standard Deviation 11.26
|
35.35 scores on a scale
Standard Deviation 10.12
|
32.23 scores on a scale
Standard Deviation 9.79
|
39.42 scores on a scale
Standard Deviation 11.25
|
37.92 scores on a scale
Standard Deviation 13.03
|
Adverse Events
RP5063 15 mg
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
RP5063 30 mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
RP5063 50 mg
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Aripiprazole 15 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RP5063 15 mg
n=58 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=59 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=58 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=20 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=38 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Investigations
Elevated liver enzyme levels
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Sedation excessive
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
Other adverse events
| Measure |
RP5063 15 mg
n=58 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
|
RP5063 30 mg
n=59 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
|
RP5063 50 mg
n=58 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
|
Aripiprazole 15 mg
n=20 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
|
Placebo
n=38 participants at risk
Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Eye disorders
Oculogyric crisis
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
General disorders
Pain
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
General disorders
Pyrexia
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.2%
3/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.3%
2/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Infections and infestations
Pyelonephritis acute
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Investigations
Hepatic enzyme increased
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Akathisia
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.1%
3/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
10.3%
6/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.1%
3/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
8.6%
5/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Headache
|
5.2%
3/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Sedation
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.2%
3/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Nervous system disorders
Tremor
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.1%
3/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Agitation
|
10.3%
6/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
10.2%
6/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
6.9%
4/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
20.0%
4/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
15.8%
6/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.3%
2/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Insomnia
|
27.6%
16/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
25.4%
15/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
17.2%
10/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
20.0%
4/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
21.1%
8/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Restlessness
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.1%
3/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
7.9%
3/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.0%
1/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
2.6%
1/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Psychiatric disorders
Social avoidant behavior
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
5.3%
2/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/59 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
3.4%
2/58 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/20 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
0.00%
0/38 • Adverse events were collected over a period of 14 months.
All subjects receiving at least one dose of investigational product were included in the safety analyses. A total of 233 subjects out of randomized 234 subjects were exposed to the investigational product, provided post-baseline safety data and were included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60