Trial Outcomes & Findings for Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (NCT NCT00705783)
NCT ID: NCT00705783
Last Updated: 2013-07-19
Results Overview
A patient experienced an 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
843 participants
Primary outcome timeframe
Baseline of the depot maintenance phase to the end of the study (Week 52)
Results posted on
2013-07-19
Participant Flow
There were 4 phases in this study. In phases 1-3 (Conversion Phase, Oral Stabilization Phase, Depot Stabilization Phase), there was a single treatment group. In phase 4 (Depot Maintenance Phase), there were 2 treatment 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. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
|
Aripiprazole Depot
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|---|
|
Conversion Phase
STARTED
|
633
|
0
|
0
|
|
Conversion Phase
Received Study Medication
|
632
|
0
|
0
|
|
Conversion Phase
COMPLETED
|
500
|
0
|
0
|
|
Conversion Phase
NOT COMPLETED
|
133
|
0
|
0
|
|
Oral Stabilization Phase
STARTED
|
710
|
0
|
0
|
|
Oral Stabilization Phase
Received Study Medication
|
709
|
0
|
0
|
|
Oral Stabilization Phase
COMPLETED
|
576
|
0
|
0
|
|
Oral Stabilization Phase
NOT COMPLETED
|
134
|
0
|
0
|
|
Depot Stabilization Phase
STARTED
|
576
|
0
|
0
|
|
Depot Stabilization Phase
COMPLETED
|
403
|
0
|
0
|
|
Depot Stabilization Phase
NOT COMPLETED
|
173
|
0
|
0
|
|
Depot Maintenance Phase
STARTED
|
0
|
269
|
134
|
|
Depot Maintenance Phase
COMPLETED
|
0
|
23
|
3
|
|
Depot Maintenance Phase
NOT COMPLETED
|
0
|
246
|
131
|
Reasons for withdrawal
| Measure |
All Patients
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
|
Aripiprazole Depot
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|---|
|
Conversion Phase
Sponsor Discontinued Study
|
54
|
0
|
0
|
|
Conversion Phase
Lost to Follow-up
|
13
|
0
|
0
|
|
Conversion Phase
Met Withdrawal Criteria
|
4
|
0
|
0
|
|
Conversion Phase
Withdrawn by Investigator
|
4
|
0
|
0
|
|
Conversion Phase
Withdrew Consent
|
24
|
0
|
0
|
|
Conversion Phase
Protocol Deviation
|
2
|
0
|
0
|
|
Conversion Phase
Adverse Event
|
11
|
0
|
0
|
|
Conversion Phase
Lack of Efficacy with Adverse Event
|
13
|
0
|
0
|
|
Conversion Phase
Lack of Efficacy without Adverse Event
|
8
|
0
|
0
|
|
Oral Stabilization Phase
Sponsor Discontinue Study
|
42
|
0
|
0
|
|
Oral Stabilization Phase
Lost to Follow-up
|
7
|
0
|
0
|
|
Oral Stabilization Phase
Met Withdrawal Criteria
|
19
|
0
|
0
|
|
Oral Stabilization Phase
Withdrawn by Investigator
|
12
|
0
|
0
|
|
Oral Stabilization Phase
Withdrew Consent
|
29
|
0
|
0
|
|
Oral Stabilization Phase
Adverse Event
|
14
|
0
|
0
|
|
Oral Stabilization Phase
Lack of Efficacy with Adverse Event
|
7
|
0
|
0
|
|
Oral Stabilization Phase
Lack of Efficacy without Adverse Event
|
4
|
0
|
0
|
|
Depot Stabilization Phase
Sponsor Discontinued Study
|
86
|
0
|
0
|
|
Depot Stabilization Phase
Lost to Follow-up
|
11
|
0
|
0
|
|
Depot Stabilization Phase
Met Withdrawal Criteria
|
8
|
0
|
0
|
|
Depot Stabilization Phase
Withdrawn by Investigator
|
9
|
0
|
0
|
|
Depot Stabilization Phase
Withdrew Consent
|
29
|
0
|
0
|
|
Depot Stabilization Phase
Adverse Event
|
17
|
0
|
0
|
|
Depot Stabilization Phase
Lack of Efficacy with Adverse Event
|
12
|
0
|
0
|
|
Depot Stabilization Phase
Lack of Efficacy without Adverse Event
|
1
|
0
|
0
|
|
Depot Maintenance Phase
Sponsor Discontinued Study
|
0
|
179
|
58
|
|
Depot Maintenance Phase
Lost to Follow-up
|
0
|
5
|
3
|
|
Depot Maintenance Phase
Met Withdrawal Criteria
|
0
|
2
|
2
|
|
Depot Maintenance Phase
Withdrawn by Investigator
|
0
|
8
|
6
|
|
Depot Maintenance Phase
Withdrew Consent
|
0
|
14
|
4
|
|
Depot Maintenance Phase
Protocol Deviation
|
0
|
2
|
0
|
|
Depot Maintenance Phase
Adverse Event without Impending Relapse
|
0
|
9
|
5
|
|
Depot Maintenance Phase
Impending Relapse with Adverse Event
|
0
|
11
|
13
|
|
Depot Maintenance Phase
Impending Relapse without Adverse Event
|
0
|
16
|
40
|
Baseline Characteristics
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole Depot
n=269 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.1 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
41.7 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
241 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients.
A patient experienced an 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
n=269 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Time to Exacerbation of Psychotic Symptoms/Impending Relapse
|
NA Days
The median and confidence interval were not estimable due to too few events.
|
209 Days
Interval 161.0 to 254.0
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients.
This is the key secondary Outcome Measure.
Outcome measures
| Measure |
Aripiprazole Depot
n=269 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria
|
10.0 Percentage of patients
|
39.6 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.
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
n=267 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Percentage of Responders
|
87.6 Percentage of patients
|
56.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.
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
n=87 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=31 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Percentage of Patients Achieving Remission
|
52.9 Percentage of patients
|
38.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole Depot
n=25 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=4 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the PANSS Total Score
|
1.43 Units on a scale
Standard Error 0.756
|
11.55 Units on a scale
Standard Error 1.066
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole Depot
n=266 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
|
0.14 Units on a scale
Standard Error 0.051
|
0.66 Units on a scale
Standard Error 0.073
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole Depot
n=266 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the PANSS Positive Subscale Score
|
0.44 Units on a scale
Standard Error 0.265
|
4.25 Units on a scale
Standard Error 0.374
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole Depot
n=266 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the PANSS Negative Subscale Score
|
0.19 Units on a scale
Standard Error 0.201
|
1.55 Units on a scale
Standard Error 0.284
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient's condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.
Outcome measures
| Measure |
Aripiprazole Depot
n=266 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=133 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Mean Clinical Global Impression-Improvement (CGI-I) Score
|
3.70 Units on a scale
Standard Deviation 1.05
|
4.53 Units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Baseline of the depot maintenance phase to the end of the study (Week 52)Population: Intent-to-treat population: All randomized patients.
Time to discontinuation was defined as the date of randomization to the date of study discontinuation.
Outcome measures
| Measure |
Aripiprazole Depot
n=269 Participants
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot
n=134 Participants
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|
|
Time to Discontinuation
|
NA Days
Interval 364.0 to
The median and the upper limit of the confidence interval were not estimable due to too few events.
|
162 Days
Interval 98.0 to 211.0
|
Adverse Events
Conversion Phase
Serious events: 13 serious events
Other events: 113 other events
Deaths: 0 deaths
Oral Stabilization Phase
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Depot Stabilization Phase
Serious events: 25 serious events
Other events: 184 other events
Deaths: 0 deaths
Aripiprazole Depot - Depot Maintenance Phase
Serious events: 11 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo Depot - Depot Maintenance Phase
Serious events: 9 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conversion Phase
n=632 participants at risk
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
|
Oral Stabilization Phase
n=709 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.
|
Depot Stabilization Phase
n=576 participants at risk
During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
|
Aripiprazole Depot - Depot Maintenance Phase
n=269 participants at risk
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot - Depot Maintenance Phase
n=134 participants at risk
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.16%
1/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.16%
1/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.16%
1/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.16%
1/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.32%
2/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.35%
2/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
1.5%
4/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.0%
4/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.95%
6/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.85%
6/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
1.6%
9/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.74%
2/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
1.5%
2/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.32%
2/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.35%
2/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.32%
2/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.74%
2/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.14%
1/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.17%
1/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.75%
1/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.75%
1/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.75%
1/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.75%
1/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.37%
1/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Conversion Phase
n=632 participants at risk
During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
|
Oral Stabilization Phase
n=709 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.
|
Depot Stabilization Phase
n=576 participants at risk
During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
|
Aripiprazole Depot - Depot Maintenance Phase
n=269 participants at risk
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
|
Placebo Depot - Depot Maintenance Phase
n=134 participants at risk
Patients received placebo intramuscularly every 28 days for 52 weeks.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
7.1%
45/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.2%
23/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.9%
34/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.9%
16/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.2%
7/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
12.0%
76/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
7.1%
50/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
8.0%
46/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
10.0%
27/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
9.0%
12/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.28%
2/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.9%
34/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.0%
8/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.7%
5/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
Weight increased
|
1.3%
8/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
2.3%
16/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
6.9%
40/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
9.7%
26/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
9.7%
13/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Akathisia
|
4.7%
30/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
4.7%
33/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
6.2%
36/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.6%
15/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
6.0%
8/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
4.3%
27/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
4.1%
29/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
6.6%
38/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.9%
16/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
7.5%
10/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
14/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
0.85%
6/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
1.9%
11/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.7%
10/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.2%
7/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
2.5%
16/632 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
2.0%
14/709 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
3.6%
21/576 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
5.9%
16/269 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All subjects who received at least 1 dose of study medication.
|
1.5%
2/134 • Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Safety population: All 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