Trial Outcomes & Findings for A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia (NCT NCT01412060)
NCT ID: NCT01412060
Last Updated: 2018-07-06
Results Overview
Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion. PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
765 participants
Primary outcome timeframe
Up to 34 Weeks and Bi-Weekly thereafter until Week 92
Results posted on
2018-07-06
Participant Flow
A total of 765 participants were enrolled and received cariprazine in Run-in Phase; 751 of these, had at least 1 postbaseline Positive and Negative Syndrome Scale (PANSS) evaluation and 364 entered Stabilization Phase. Only 200 participants who completed Open-label phase, received either placebo (n=99) or cariprazine (n=101) in Double-Blind Phase.
Participant milestones
| Measure |
Cariprazine - Open-label Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
|
Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
|
Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
|
|---|---|---|---|
|
Open-label Run-in Period (RIP)
STARTED
|
765
|
0
|
0
|
|
Open-label Run-in Period (RIP)
COMPLETED
|
418
|
0
|
0
|
|
Open-label Run-in Period (RIP)
NOT COMPLETED
|
347
|
0
|
0
|
|
Period Between RIP and SP
STARTED
|
418
|
0
|
0
|
|
Period Between RIP and SP
COMPLETED
|
364
|
0
|
0
|
|
Period Between RIP and SP
NOT COMPLETED
|
54
|
0
|
0
|
|
Open-label Stabilization Period (SP)
STARTED
|
364
|
0
|
0
|
|
Open-label Stabilization Period (SP)
COMPLETED
|
264
|
0
|
0
|
|
Open-label Stabilization Period (SP)
NOT COMPLETED
|
100
|
0
|
0
|
|
Period Between SP and DBP
STARTED
|
264
|
0
|
0
|
|
Period Between SP and DBP
COMPLETED
|
200
|
0
|
0
|
|
Period Between SP and DBP
NOT COMPLETED
|
64
|
0
|
0
|
|
Double-blind Treatment Phase (DBP)
STARTED
|
0
|
99
|
101
|
|
Double-blind Treatment Phase (DBP)
COMPLETED
|
0
|
16
|
18
|
|
Double-blind Treatment Phase (DBP)
NOT COMPLETED
|
0
|
83
|
83
|
Reasons for withdrawal
| Measure |
Cariprazine - Open-label Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
|
Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
|
Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
|
|---|---|---|---|
|
Open-label Run-in Period (RIP)
Adverse Event
|
86
|
0
|
0
|
|
Open-label Run-in Period (RIP)
Insufficient Therapeutic Response
|
66
|
0
|
0
|
|
Open-label Run-in Period (RIP)
Protocol Violation
|
27
|
0
|
0
|
|
Open-label Run-in Period (RIP)
Withdrawal of Consent
|
117
|
0
|
0
|
|
Open-label Run-in Period (RIP)
Lost to Follow-up
|
32
|
0
|
0
|
|
Open-label Run-in Period (RIP)
Other Miscellaneous Reasons
|
19
|
0
|
0
|
|
Period Between RIP and SP
Adverse Event
|
4
|
0
|
0
|
|
Period Between RIP and SP
Insufficient Therapeutic Response
|
19
|
0
|
0
|
|
Period Between RIP and SP
Protocol Violation
|
2
|
0
|
0
|
|
Period Between RIP and SP
Withdrawal of Consent
|
1
|
0
|
0
|
|
Period Between RIP and SP
Lost to Follow-up
|
5
|
0
|
0
|
|
Period Between RIP and SP
Other Miscellaneous Reasons
|
23
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Adverse Event
|
9
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Insufficient Therapeutic Response
|
9
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Protocol Violation
|
14
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Withdrawal of Consent
|
40
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Lost to Follow-up
|
9
|
0
|
0
|
|
Open-label Stabilization Period (SP)
Other Miscellaneous Reasons
|
19
|
0
|
0
|
|
Period Between SP and DBP
Protocol Violation
|
2
|
0
|
0
|
|
Period Between SP and DBP
Withdrawal of Consent
|
2
|
0
|
0
|
|
Period Between SP and DBP
Lost to Follow-up
|
1
|
0
|
0
|
|
Period Between SP and DBP
Did Not Met Criteria to Enter Next Phase
|
4
|
0
|
0
|
|
Period Between SP and DBP
Other Miscellaneous Reasons
|
55
|
0
|
0
|
|
Double-blind Treatment Phase (DBP)
Adverse Event
|
0
|
5
|
6
|
|
Double-blind Treatment Phase (DBP)
Protocol Violation
|
0
|
4
|
5
|
|
Double-blind Treatment Phase (DBP)
Withdrawal of Consent
|
0
|
10
|
15
|
|
Double-blind Treatment Phase (DBP)
Lost to Follow-up
|
0
|
6
|
5
|
|
Double-blind Treatment Phase (DBP)
Other Miscellaneous Reasons
|
0
|
11
|
27
|
|
Double-blind Treatment Phase (DBP)
Relapse
|
0
|
47
|
25
|
Baseline Characteristics
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Cariprazine - Open-label Phase
n=765 Participants
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
|
|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
544 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
728 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
313 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
299 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
78.07 kg
STANDARD_DEVIATION 20.10 • n=5 Participants
|
|
Height
|
170.98 cm
STANDARD_DEVIATION 9.95 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.50 kg/m^2
STANDARD_DEVIATION 5.63 • n=5 Participants
|
|
Waist circumference
|
90.39 cm
STANDARD_DEVIATION 15.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 34 Weeks and Bi-Weekly thereafter until Week 92Population: Double-blind intent-to-treat population: All participants who received at least 1 dose of double-blind investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the Double-blind Treatment Phase.
Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion. PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received placebo orally once a day for 26 to 72 weeks. Placebo: Placebo was supplied in capsules.
|
Cariprazine
n=101 Participants
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks. Cariprazine: Cariprazine was supplied in capsules.
|
|---|---|---|
|
Time From Baseline to the First Symptom Relapse During the Double-blind Phase
|
92 Days
Interval 44.0 to 151.0
|
224 Days
Interval 99.0 to
The upper limit of the confidence interval could not be calculated due to insufficient number of events.
|
Adverse Events
Cariprazine - Open-label Phase
Serious events: 50 serious events
Other events: 425 other events
Deaths: 0 deaths
Placebo - Double-blind Treatment Phase
Serious events: 14 serious events
Other events: 28 other events
Deaths: 0 deaths
Cariprazine - Double-blind Treatment Phase
Serious events: 14 serious events
Other events: 35 other events
Deaths: 0 deaths
Open-label - Safety Follow-up Phase
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo - Safety Follow-up Phase
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Cariprazine - Safety Follow-up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cariprazine - Open-label Phase
n=765 participants at risk
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
|
Placebo - Double-blind Treatment Phase
n=99 participants at risk
Participants received placebo orally once a day for 26 to 72 weeks.
|
Cariprazine - Double-blind Treatment Phase
n=101 participants at risk
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
|
Open-label - Safety Follow-up Phase
n=765 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
Placebo - Safety Follow-up Phase
n=99 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
Cariprazine - Safety Follow-up Phase
n=101 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
2.5%
19/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.1%
7/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
5.0%
5/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.39%
3/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Psychotic disorder
|
1.3%
10/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
2.0%
2/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
2.0%
2/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.39%
3/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Suicidal ideation
|
0.65%
5/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.39%
3/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
2.0%
2/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Social circumstances
Social stay hospitalisation
|
0.26%
2/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Convulsion
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Drug abuse
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Insomnia
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Surgical and medical procedures
Intentional product misuse
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Infections and infestations
Pneumonia
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Investigations
Psychiatric evaluation
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Psychotic behaviour
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
General disorders
Pyrexia
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Restlessness
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Social circumstances
Victim of crime
|
0.13%
1/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
General disorders
Drug ineffective
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.99%
1/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
1.0%
1/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
Other adverse events
| Measure |
Cariprazine - Open-label Phase
n=765 participants at risk
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
|
Placebo - Double-blind Treatment Phase
n=99 participants at risk
Participants received placebo orally once a day for 26 to 72 weeks.
|
Cariprazine - Double-blind Treatment Phase
n=101 participants at risk
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
|
Open-label - Safety Follow-up Phase
n=765 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
Placebo - Safety Follow-up Phase
n=99 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
Cariprazine - Safety Follow-up Phase
n=101 participants at risk
Participants received no treatment during the 4 weeks Safety Follow-up Phase.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.1%
39/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
46/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
48/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Investigations
Weight increased
|
6.4%
49/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Akathisia
|
19.3%
148/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Extrapyramidal disorder
|
7.2%
55/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
3.0%
3/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
5.9%
6/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Headache
|
12.0%
92/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.1%
7/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.9%
8/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Anxiety
|
5.1%
39/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Insomnia
|
14.4%
110/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
8.1%
8/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.9%
8/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Restlessness
|
9.2%
70/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
5.1%
5/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
4.0%
4/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
5.1%
5/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.9%
8/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Nervous system disorders
Tremor
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
7.9%
8/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
6.1%
6/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
4.0%
4/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/765 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/99 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
0.00%
0/101 • First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study. Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product. Adverse events data was reported in periods as per the treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER