Trial Outcomes & Findings for Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (NCT NCT00706654)
NCT ID: NCT00706654
Last Updated: 2013-08-14
Results Overview
A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score \> 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score \> 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
937 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2013-08-14
Participant Flow
There were 3 phases in this study. In phases 1 and 2 (Conversion Phase and Oral Stabilization Phase), there was 1 reporting group. In phase 3 (Depot Maintenance Phase), there were 3 reporting groups. All Outcome Measures were assessed in the Depot Maintenance Phase of the study.
Participant milestones
| Measure |
All Patients
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
|
Aripiprazole Depot 300 or 400 mg
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|---|
|
Conversion Phase
STARTED
|
709
|
0
|
0
|
0
|
|
Conversion Phase
COMPLETED
|
614
|
0
|
0
|
0
|
|
Conversion Phase
NOT COMPLETED
|
95
|
0
|
0
|
0
|
|
Oral Stabilization Phase
STARTED
|
842
|
0
|
0
|
0
|
|
Oral Stabilization Phase
COMPLETED
|
662
|
0
|
0
|
0
|
|
Oral Stabilization Phase
NOT COMPLETED
|
180
|
0
|
0
|
0
|
|
Depot Maintenance Phase
STARTED
|
0
|
265
|
266
|
131
|
|
Depot Maintenance Phase
COMPLETED
|
0
|
196
|
178
|
61
|
|
Depot Maintenance Phase
NOT COMPLETED
|
0
|
69
|
88
|
70
|
Reasons for withdrawal
| Measure |
All Patients
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
|
Aripiprazole Depot 300 or 400 mg
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|---|
|
Conversion Phase
Lost to Follow-up
|
4
|
0
|
0
|
0
|
|
Conversion Phase
Sponsor Discontinued Trial
|
8
|
0
|
0
|
0
|
|
Conversion Phase
Met Withdrawal Criteria
|
2
|
0
|
0
|
0
|
|
Conversion Phase
Withdrawn by Investigator
|
14
|
0
|
0
|
0
|
|
Conversion Phase
Withdrew Consent
|
38
|
0
|
0
|
0
|
|
Conversion Phase
Adverse Event
|
18
|
0
|
0
|
0
|
|
Conversion Phase
Lack of Efficacy with Adverse Event
|
9
|
0
|
0
|
0
|
|
Conversion Phase
Lack of Efficacy without Adverse Event
|
2
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Lost to Follow-up
|
17
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Sponsor Discontinue Trial
|
19
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Met Withdrawal Criteria
|
15
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Withdrawn by Investigator
|
21
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Withdrew consent
|
55
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Protocol Deviation
|
2
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Adverse Event
|
21
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Lack of Efficacy with Adverse Event
|
20
|
0
|
0
|
0
|
|
Oral Stabilization Phase
Lack of Efficacy without Adverse Event
|
10
|
0
|
0
|
0
|
|
Depot Maintenance Phase
Lost to Follow-up
|
0
|
4
|
10
|
6
|
|
Depot Maintenance Phase
Met Withdrawal Criteria
|
0
|
4
|
6
|
5
|
|
Depot Maintenance Phase
Withdrawn by Investigator
|
0
|
8
|
12
|
8
|
|
Depot Maintenance Phase
Withdrew Consent
|
0
|
21
|
29
|
14
|
|
Depot Maintenance Phase
Protocol Deviation
|
0
|
2
|
3
|
1
|
|
Depot Maintenance Phase
Adverse Event without Impending Relapse
|
0
|
8
|
7
|
7
|
|
Depot Maintenance Phase
Impending Relapse with Adverse Event
|
0
|
13
|
12
|
17
|
|
Depot Maintenance Phase
Impending Relapse without Adverse Event
|
0
|
9
|
9
|
12
|
Baseline Characteristics
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=265 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=266 Participants
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=131 Participants
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
Total
n=662 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
41.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
256 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
406 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: Intent-to-treat population: All randomized patients.
A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score \> 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score \> 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
Outcome measures
| Measure |
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=265 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=266 Participants
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=131 Participants
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|
|
Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26
|
7.12 Percentage of patients
1.62
|
7.76 Percentage of patients
1.72
|
21.80 Percentage of patients
3.97
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 38)Population: Intent-to-treat population: All randomized patients.
Outcome measures
| Measure |
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=265 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=266 Participants
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=131 Participants
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|
|
Time to Exacerbation of Psychotic Symptoms/Impending Relapse
|
NA Days
95% Confidence Interval NA
Due to the low (\< 50%) percentage of relapses, median time to exacerbation could not be estimated.
|
NA Days
95% Confidence Interval NA
Due to the low (\< 50%) percentage of relapses, median time to exacerbation could not be estimated.
|
NA Days
95% Confidence Interval NA
Due to the low (\< 50%) percentage of relapses, median time to exacerbation could not be estimated.
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 38)Population: Intent-to-treat population: All randomized patients.
A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.
Outcome measures
| Measure |
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=264 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=263 Participants
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=129 Participants
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|
|
Percentage of Responders up to Week 38
|
89.8 Percentage of patients
|
89.4 Percentage of patients
|
75.2 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (Week 38)Population: Intent-to-treat population: All randomized patients.
A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).
Outcome measures
| Measure |
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=215 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=201 Participants
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=72 Participants
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|
|
Percentage of Patients Achieving Remission
|
48.8 Percentage of patients
|
53.2 Percentage of patients
|
59.7 Percentage of patients
|
Adverse Events
All Patients - Conversion Phase
Serious events: 21 serious events
Other events: 140 other events
Deaths: 0 deaths
All Patients - Oral Stabilization Phase
Serious events: 39 serious events
Other events: 177 other events
Deaths: 0 deaths
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
Serious events: 15 serious events
Other events: 161 other events
Deaths: 0 deaths
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
Serious events: 15 serious events
Other events: 142 other events
Deaths: 0 deaths
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Serious events: 11 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients - Conversion Phase
n=709 participants at risk
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
|
All Patients - Oral Stabilization Phase
n=842 participants at risk
During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
|
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=265 participants at risk
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=266 participants at risk
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=131 participants at risk
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.24%
2/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
1.1%
8/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.8%
15/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.5%
4/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.75%
2/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
3.1%
4/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.42%
3/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.1%
9/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.9%
5/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.75%
2/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
2.3%
3/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.75%
2/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
2/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.48%
4/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Drug abuse
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.28%
2/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.38%
1/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Hernia
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischemic attack
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic behaviour
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
All Patients - Conversion Phase
n=709 participants at risk
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
|
All Patients - Oral Stabilization Phase
n=842 participants at risk
During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
|
Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase
n=265 participants at risk
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
|
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
n=266 participants at risk
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
|
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
n=131 participants at risk
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.9%
28/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
4.2%
35/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
7.2%
19/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
4.9%
13/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
7.6%
10/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.71%
5/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.83%
7/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.1%
3/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.1%
3/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
6.1%
8/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Akathisia
|
5.1%
36/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
7.5%
63/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
10.6%
28/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
6.8%
18/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
8.4%
11/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.5%
39/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
5.2%
44/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
9.8%
26/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
11.3%
30/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
5.3%
7/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
11.0%
78/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
10.3%
87/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
11.7%
31/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
13.9%
37/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
13.7%
18/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.12%
1/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
7.5%
20/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
2.3%
6/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
0.76%
1/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
1.3%
9/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.2%
10/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
4.2%
11/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
4.1%
11/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
5.3%
7/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
17/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
2.1%
18/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
7.9%
21/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
9.4%
25/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
6.9%
9/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
14/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.4%
12/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
6.8%
18/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
4.1%
11/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
3.8%
5/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
1.4%
10/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
3.0%
25/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
9.8%
26/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
6.0%
16/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
9.2%
12/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Investigations
Weight increased
|
0.71%
5/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
2.7%
23/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
9.1%
24/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
13.2%
35/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
5.3%
7/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
1.7%
14/842 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
3.8%
10/265 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
5.3%
14/266 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
11.5%
15/131 • Adverse events were reported from the time of the signing of informed consent until the end of the study.
Safety population: All randomized subjects who received at least 1 dose of study medication.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place