Trial Outcomes & Findings for Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia (NCT NCT03593213)
NCT ID: NCT03593213
Last Updated: 2022-04-11
Results Overview
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: * Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score \<50 at randomization \[PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms\] * Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points \[1=normal to 7=among most extremely ill\] * Score of \>4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control * Deliberate self-injury * Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance * Psychiatric hospitalization * Exacerbation of psychiatric illness
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
587 participants
Primary outcome timeframe
Randomization (Week 18) to End of Treatment (Week 44)
Results posted on
2022-04-11
Participant Flow
Participant milestones
| Measure |
Cariprazine 4.5 mg/Day (Open-label Treatment Period)
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
|
Placebo (Double-blind Treatment Period)
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
|---|---|---|---|---|
|
Open-label Treatment Period (18 Weeks)
STARTED
|
587
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
COMPLETED
|
162
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
NOT COMPLETED
|
425
|
0
|
0
|
0
|
|
Double-blind Treatment Period (26 Weeks)
STARTED
|
0
|
54
|
49
|
56
|
|
Double-blind Treatment Period (26 Weeks)
Safety Population
|
0
|
53
|
49
|
54
|
|
Double-blind Treatment Period (26 Weeks)
COMPLETED
|
0
|
14
|
16
|
21
|
|
Double-blind Treatment Period (26 Weeks)
NOT COMPLETED
|
0
|
40
|
33
|
35
|
Reasons for withdrawal
| Measure |
Cariprazine 4.5 mg/Day (Open-label Treatment Period)
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
|
Placebo (Double-blind Treatment Period)
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
|---|---|---|---|---|
|
Open-label Treatment Period (18 Weeks)
Adverse Event
|
39
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Lack of Efficacy
|
14
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Withdrawal by Subject
|
85
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Lost to Follow-up
|
51
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Death
|
1
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Protocol Deviation
|
5
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Non-compliance with Study Drug
|
23
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Study Terminated by the Sponsor
|
90
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Reason not Specified
|
13
|
0
|
0
|
0
|
|
Open-label Treatment Period (18 Weeks)
Failure to Meet Randomization Criteria
|
104
|
0
|
0
|
0
|
|
Double-blind Treatment Period (26 Weeks)
Number of Participants with Relapse Event
|
0
|
15
|
9
|
8
|
|
Double-blind Treatment Period (26 Weeks)
Adverse Event
|
0
|
2
|
0
|
4
|
|
Double-blind Treatment Period (26 Weeks)
Withdrawal by Subject
|
0
|
4
|
2
|
3
|
|
Double-blind Treatment Period (26 Weeks)
Lost to Follow-up
|
0
|
5
|
4
|
1
|
|
Double-blind Treatment Period (26 Weeks)
Pregnancy
|
0
|
0
|
0
|
1
|
|
Double-blind Treatment Period (26 Weeks)
Protocol Deviation
|
0
|
3
|
2
|
5
|
|
Double-blind Treatment Period (26 Weeks)
Non-compliance with Study Drug
|
0
|
1
|
2
|
0
|
|
Double-blind Treatment Period (26 Weeks)
Study Terminated by Sponsor
|
0
|
9
|
11
|
13
|
|
Double-blind Treatment Period (26 Weeks)
Reason not Specified
|
0
|
1
|
3
|
0
|
Baseline Characteristics
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo (Double-blind Treatment Period)
n=53 Participants
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
n=49 Participants
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
n=54 Participants
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 10.92 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 18) to End of Treatment (Week 44)Population: The Double-blind Intent-to Treat (DB ITT) population included all participants in the DB safety population who had at least 1 post-randomization assessment of the PANSS or CGI-S scores during the DB treatment period of the study.
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: * Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score \<50 at randomization \[PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms\] * Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points \[1=normal to 7=among most extremely ill\] * Score of \>4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control * Deliberate self-injury * Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance * Psychiatric hospitalization * Exacerbation of psychiatric illness
Outcome measures
| Measure |
Placebo (Double-blind Treatment Period)
n=53 Participants
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
n=49 Participants
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
n=53 Participants
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
|---|---|---|---|
|
Time to First Relapse During Double-blind Treatment Period
|
NA days
Interval 183.0 to
The median, and upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with event.
|
NA days
Interval 184.0 to
The median, and upper limit of 95% CI was not estimable due to low number of participants with event.
|
NA days
The median, lower and upper limit of 95% CI was not estimable due to low number of participants with event.
|
Adverse Events
Cariprazine 4.5 mg/Day (Open-label Treatment Period)
Serious events: 20 serious events
Other events: 83 other events
Deaths: 1 deaths
Cariprazine 4.5 mg/Day (Open-label Safety Follow-up)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Double-blind Treatment Period)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (Double-blind Safety Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cariprazine 4.5 mg/Day (Open-label Treatment Period)
n=587 participants at risk
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
|
Cariprazine 4.5 mg/Day (Open-label Safety Follow-up)
n=273 participants at risk
Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Open-label Treatment Period for participants who did not continue to the Double-blind Treatment Period.
|
Placebo (Double-blind Treatment Period)
n=53 participants at risk
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
n=49 participants at risk
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
n=54 participants at risk
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Placebo (Double-blind Safety Follow-up)
n=53 participants at risk
Safety Follow-up Period following treatment with Placebo in the Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up)
n=49 participants at risk
Safety Follow-up Period following treatment with Cariprazine 3.0 mg/day in the Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up)
n=54 participants at risk
Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Double-blind Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Nervous system disorders
Seizure
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Schizophrenia
|
0.68%
4/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.73%
2/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
7.5%
4/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Delusion
|
0.34%
2/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Paranoia
|
0.34%
2/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Psychotic disorder
|
0.34%
2/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.37%
1/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Agitation
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Hallucination, tactile
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Homicidal ideation
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Mental disorder
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Suicidal ideation
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.37%
1/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Suicide attempt
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.37%
1/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Social circumstances
Homicide
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Social circumstances
Miscarriage of partner
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Social circumstances
Social stay hospitalisation
|
0.17%
1/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.37%
1/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.37%
1/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/188 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.1%
1/95 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/14 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/17 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/22 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/14 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/17 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/22 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
Other adverse events
| Measure |
Cariprazine 4.5 mg/Day (Open-label Treatment Period)
n=587 participants at risk
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
|
Cariprazine 4.5 mg/Day (Open-label Safety Follow-up)
n=273 participants at risk
Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Open-label Treatment Period for participants who did not continue to the Double-blind Treatment Period.
|
Placebo (Double-blind Treatment Period)
n=53 participants at risk
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Treatment Period)
n=49 participants at risk
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Treatment Period)
n=54 participants at risk
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
|
Placebo (Double-blind Safety Follow-up)
n=53 participants at risk
Safety Follow-up Period following treatment with Placebo in the Double-blind Treatment Period.
|
Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up)
n=49 participants at risk
Safety Follow-up Period following treatment with Cariprazine 3.0 mg/day in the Double-blind Treatment Period.
|
Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up)
n=54 participants at risk
Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Double-blind Treatment Period.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.5%
38/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Psychiatric disorders
Insomnia
|
8.5%
50/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
8.2%
4/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
2.0%
1/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
3.8%
2/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
6.1%
3/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/587 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/273 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
5.7%
3/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
4.1%
2/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
1.9%
1/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/53 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/49 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/54 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/188 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/95 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/14 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/17 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/22 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/14 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
5.9%
1/17 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
0.00%
0/22 • First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)
All-cause mortality included all participants. Open-label (OL) Safety Population (OLTP) included all participants in the screened population who took at least 1 dose of OL cariprazine during the OLTP of the study. DB safety population included all participants in the randomized population who took at least 1 dose of DB IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER