Trial Outcomes & Findings for Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia (NCT NCT01397786)
NCT ID: NCT01397786
Last Updated: 2017-05-10
Results Overview
A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1044 participants
Primary outcome timeframe
From Baseline up to 52 Weeks
Results posted on
2017-05-10
Participant Flow
This trial was conducted in a total of 1072 participants (1044 of whom entered the open-label treatment phase) at 202 trial sites in the following 18 countries: Japan, Korea, Malaysia, Philippines, Taiwan, Croatia, Latvia, Poland, Romania, Russia, Serbia, Turkey, Ukraine, Columbia, Mexico, Canada, Puerto Rico, and United States of America (USA).
Enrollment was drawn from eligible participants who could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia and included rollover participants from the double-blind, phase-3 efficacy trials (ie, Trial NCT01393613, Trial NCT01396421, and Trial NCT01668797) and de novo participants from select sites.
Participant milestones
| Measure |
Prior Brexpiprazole
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
|
Prior Placebo
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|
|
Phase A
STARTED
|
12
|
0
|
227
|
|
Phase A
COMPLETED
|
12
|
0
|
199
|
|
Phase A
NOT COMPLETED
|
0
|
0
|
28
|
|
Phase B
STARTED
|
611
|
204
|
229
|
|
Phase B
COMPLETED
|
308
|
109
|
91
|
|
Phase B
NOT COMPLETED
|
303
|
95
|
138
|
Reasons for withdrawal
| Measure |
Prior Brexpiprazole
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
|
Prior Placebo
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|
|
Phase A
Lost to Follow-up
|
0
|
0
|
6
|
|
Phase A
Adverse Event
|
0
|
0
|
8
|
|
Phase A
Subject Met Withdrawal Criteria
|
0
|
0
|
7
|
|
Phase A
Physician Decision
|
0
|
0
|
1
|
|
Phase A
Withdrawal by Subject
|
0
|
0
|
5
|
|
Phase A
Lack of Efficacy
|
0
|
0
|
1
|
|
Phase B
Lost to Follow-up
|
22
|
12
|
22
|
|
Phase B
Adverse Event
|
109
|
23
|
27
|
|
Phase B
Subject Met Withdrawal Criteria
|
38
|
5
|
38
|
|
Phase B
Physician Decision
|
9
|
1
|
3
|
|
Phase B
Withdrawal by Subject
|
102
|
45
|
30
|
|
Phase B
Protocol Deviation
|
1
|
2
|
4
|
|
Phase B
Lack of Efficacy
|
22
|
7
|
14
|
Baseline Characteristics
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
Prior Brexpiprazole
n=611 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=204 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=257 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1072 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 participants
STANDARD_DEVIATION 10.8 • n=5 Participants
|
39.6 participants
STANDARD_DEVIATION 10.8 • n=7 Participants
|
44.1 participants
STANDARD_DEVIATION 11.1 • n=5 Participants
|
40.0 participants
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
366 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
663 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score.
A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.
Outcome measures
| Measure |
Prior Brexpiprazole
n=605 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=202 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=224 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1031 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
With AEs
|
60.2 percentage of participants
|
56.4 percentage of participants
|
65.2 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
With TEAEs
|
60.0 percentage of participants
|
56.4 percentage of participants
|
65.2 percentage of participants
|
60.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
With SAEs
|
14.9 percentage of participants
|
8.9 percentage of participants
|
11.2 percentage of participants
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) \& 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel.
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=223 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score
At Week 26 (Participant count=375,134,123,632)
|
-6.90 Units on a scale
Standard Deviation 12.90
|
-12.50 Units on a scale
Standard Deviation 14.90
|
-6.60 Units on a scale
Standard Deviation 13.60
|
-8.00 Units on a scale
Standard Deviation 13.60
|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score
At Week 52 (Participant count= 226,93,91,410)
|
-11.0 Units on a scale
Standard Deviation 14.40
|
-18.40 Units on a scale
Standard Deviation 16.90
|
-8.80 Units on a scale
Standard Deviation 12.60
|
-12.20 Units on a scale
Standard Deviation 15.00
|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score
At Last Visit (Participant count=591,198,223,1012)
|
-3.80 Units on a scale
Standard Deviation 16.70
|
-9.70 Units on a scale
Standard Deviation 18.70
|
-3.50 Units on a scale
Standard Deviation 14.30
|
-4.90 Units on a scale
Standard Deviation 16.80
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility.
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Positive Subscale Score
At Week 26 (Participant count=375,134,123,632)
|
-2.10 Units on a scale
Standard Deviation 4.50
|
-4.10 Units on a scale
Standard Deviation 5.40
|
-1.70 Units on a scale
Standard Deviation 4.30
|
-2.40 Units on a scale
Standard Deviation 4.70
|
|
Mean Change From Baseline in PANSS Positive Subscale Score
At Week 52 (Participant count=226,93,91,410)
|
-3.20 Units on a scale
Standard Deviation 4.60
|
-5.80 Units on a scale
Standard Deviation 5.20
|
-2.30 Units on a scale
Standard Deviation 4.10
|
-3.60 Units on a scale
Standard Deviation 4.80
|
|
Mean Change From Baseline in PANSS Positive Subscale Score
At Last Visit (Participant count=591,198,223,1012)
|
-0.90 Units on a scale
Standard Deviation 5.90
|
-2.80 Units on a scale
Standard Deviation 6.40
|
-1.00 Units on a scale
Standard Deviation 4.90
|
-1.30 Units on a scale
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=223 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Negative Subscale Score
At Week 26 (Participant count=375,134,123,632)
|
-1.40 Units on a scale
Standard Deviation 3.70
|
-2.40 Units on a scale
Standard Deviation 4.30
|
-1.30 Units on a scale
Standard Deviation 3.80
|
-1.60 Units on a scale
Standard Deviation 3.90
|
|
Mean Change From Baseline in PANSS Negative Subscale Score
At Week 52 (Participant count=226,93,91,410)
|
-2.70 Units on a scale
Standard Deviation 4.50
|
-3.70 Units on a scale
Standard Deviation 5.40
|
-2.00 Units on a scale
Standard Deviation 3.70
|
-2.80 Units on a scale
Standard Deviation 4.60
|
|
Mean Change From Baseline in PANSS Negative Subscale Score
At Last Visit (Participant count=591,198,223,1012)
|
-1.00 Units on a scale
Standard Deviation 4.10
|
-2.40 Units on a scale
Standard Deviation 5.00
|
-0.60 Units on a scale
Standard Deviation 4.20
|
-1.20 Units on a scale
Standard Deviation 4.30
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=223 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score
At at Week 26 (Participant count=375,134,123,632)
|
-0.35 Units on a scale
Standard Deviation 0.79
|
-0.60 Units on a scale
Standard Deviation 0.98
|
-0.24 Units on a scale
Standard Deviation 0.88
|
-0.38 Units on a scale
Standard Deviation 0.86
|
|
Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score
At Week 52 (Participant count=226,93,91,410)
|
-0.55 Units on a scale
Standard Deviation 0.86
|
-0.97 Units on a scale
Standard Deviation 0.98
|
-0.48 Units on a scale
Standard Deviation 0.86
|
-0.63 Units on a scale
Standard Deviation 0.91
|
|
Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score
At Last Visit (Participant count=591,198,223,1012)
|
-0.14 Units on a scale
Standard Deviation 1.04
|
-0.46 Units on a scale
Standard Deviation 1.12
|
-0.17 Units on a scale
Standard Deviation 0.88
|
-0.21 Units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Personal and Social Performance Scale Total Score
At Week 26 (Participant count=366,134,123,623)
|
4.50 Units on a scale
Standard Deviation 9.70
|
6.50 Units on a scale
Standard Deviation 11.30
|
4.50 Units on a scale
Standard Deviation 9.00
|
4.90 Units on a scale
Standard Deviation 10.00
|
|
Mean Change From Baseline in Personal and Social Performance Scale Total Score
At Week 52 (Participant count=223,93,91,407)
|
7.00 Units on a scale
Standard Deviation 10.60
|
9.60 Units on a scale
Standard Deviation 11.90
|
7.60 Units on a scale
Standard Deviation 10.80
|
7.70 Units on a scale
Standard Deviation 11.00
|
|
Mean Change From Baseline in Personal and Social Performance Scale Total Score
At Last Visit (Participant count=569,196,219,984)
|
1.80 Units on a scale
Standard Deviation 12.40
|
5.10 Units on a scale
Standard Deviation 12.80
|
2.70 Units on a scale
Standard Deviation 11.00
|
2.70 Units on a scale
Standard Deviation 12.20
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Outcome measures
| Measure |
Prior Brexpiprazole
n=598 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Clinical Global Impression - Improvement Score
At Week 26 (Participant count=381,134,123,638)
|
3.00 Units on a scale
Standard Deviation 1.13
|
2.77 Units on a scale
Standard Deviation 0.99
|
3.00 Units on a scale
Standard Deviation 1.13
|
2.95 Units on a scale
Standard Deviation 1.10
|
|
Mean Clinical Global Impression - Improvement Score
At Week 52 (Participant count=226,93,91,410)
|
2.66 Units on a scale
Standard Deviation 1.13
|
2.26 Units on a scale
Standard Deviation 0.97
|
2.76 Units on a scale
Standard Deviation 1.09
|
2.59 Units on a scale
Standard Deviation 1.10
|
|
Mean Clinical Global Impression - Improvement Score
At Last Visit (Participant count=598,198,223,1019)
|
3.31 Units on a scale
Standard Deviation 1.43
|
2.96 Units on a scale
Standard Deviation 1.33
|
3.30 Units on a scale
Standard Deviation 1.27
|
3.24 Units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
Outcome measures
| Measure |
Prior Brexpiprazole
n=605 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=202 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=224 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1031 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Response Rate
|
34.2 percentage of participants
|
42.6 percentage of participants
|
27.2 percentage of participants
|
34.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Discontinuation rate for the participants who discontinued due to lack of efficacy were examined.
Outcome measures
| Measure |
Prior Brexpiprazole
n=605 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=202 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=224 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1031 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Discontinuation Rate for Lack of Efficacy
|
3.6 percentage of participants
|
3.5 percentage of participants
|
6.3 percentage of participants
|
4.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score
At Week 26 (Participant count=375,134,123,632)
|
-0.60 Units on a scale
Standard Deviation 3.10
|
-1.80 Units on a scale
Standard Deviation 3.70
|
-0.70 Units on a scale
Standard Deviation 3.10
|
-0.90 Units on a scale
Standard Deviation 3.30
|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score
At Week 52 (Participant count=226,93,91,410)
|
-1.20 Units on a scale
Standard Deviation 3.20
|
-2.60 Units on a scale
Standard Deviation 3.40
|
-1.00 Units on a scale
Standard Deviation 2.90
|
-1.50 Units on a scale
Standard Deviation 3.20
|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score
At Last Visit (Participant count=591,198,223,1012)
|
0.10 Units on a scale
Standard Deviation 4.10
|
-0.90 Units on a scale
Standard Deviation 4.20
|
-0.30 Units on a scale
Standard Deviation 3.50
|
-0.20 Units on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score
At Week 26 (Participant count=375,134,123,632)
|
-2.60 Units on a scale
Standard Deviation 4.80
|
-4.70 Units on a scale
Standard Deviation 5.50
|
-2.00 Units on a scale
Standard Deviation 5.20
|
-2.90 Units on a scale
Standard Deviation 5.10
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score
At Week 52 (Participant count=226,93,91,410)
|
-3.90 Units on a scale
Standard Deviation 5.20
|
-6.60 Units on a scale
Standard Deviation 5.70
|
-2.60 Units on a scale
Standard Deviation 4.80
|
-4.20 Units on a scale
Standard Deviation 5.40
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score
At Last Visit (Participant count=591,198,223,1012)
|
-1.60 Units on a scale
Standard Deviation 5.90
|
-3.50 Units on a scale
Standard Deviation 6.50
|
-1.30 Units on a scale
Standard Deviation 5.00
|
-1.90 Units on a scale
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score
At Week 26 (Participant count=375,134,123,632)
|
-1.50 Units on a scale
Standard Deviation 3.60
|
-2.20 Units on a scale
Standard Deviation 4.00
|
-1.70 Units on a scale
Standard Deviation 4.10
|
-1.70 Units on a scale
Standard Deviation 3.80
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score
At Week 52 (Participant count=226,93,91,410)
|
-2.60 Units on a scale
Standard Deviation 4.30
|
-3.90 Units on a scale
Standard Deviation 5.00
|
-2.20 Units on a scale
Standard Deviation 3.80
|
-2.80 Units on a scale
Standard Deviation 4.40
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score
At Last Visit (Participant count=591,198,223,1012)
|
-1.00 Units on a scale
Standard Deviation 4.10
|
-2.30 Units on a scale
Standard Deviation 5.10
|
-0.70 Units on a scale
Standard Deviation 4.10
|
-1.20 Units on a scale
Standard Deviation 4.40
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score
At Week 26 (Participant count=375,134,123,632)
|
-1.70 Units on a scale
Standard Deviation 3.30
|
-2.60 Units on a scale
Standard Deviation 3.50
|
-1.70 Units on a scale
Standard Deviation 3.50
|
-1.90 Units on a scale
Standard Deviation 3.40
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score
At Week 52 (Participant count=226,93,91,410)
|
-2.90 Units on a scale
Standard Deviation 3.70
|
-3.70 Units on a scale
Standard Deviation 4.60
|
-2.30 Units on a scale
Standard Deviation 3.70
|
-2.90 Units on a scale
Standard Deviation 4.00
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score
At Last Visit (Participant count=591,198,223,1012)
|
-1.20 Units on a scale
Standard Deviation 4.20
|
-2.20 Units on a scale
Standard Deviation 4.50
|
-0.90 Units on a scale
Standard Deviation 4.00
|
-1.40 Units on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score
At Week 26 (Participant count=375,134,123,632)
|
-0.40 Units on a scale
Standard Deviation 2.70
|
-1.40 Units on a scale
Standard Deviation 3.10
|
-0.60 Units on a scale
Standard Deviation 2.60
|
-0.60 Units on a scale
Standard Deviation 2.80
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score
At Week 52 (Participant count=226,93,91,410)
|
-0.80 Units on a scale
Standard Deviation 2.70
|
-1.90 Units on a scale
Standard Deviation 2.90
|
-0.90 Units on a scale
Standard Deviation 2.30
|
-1.10 Units on a scale
Standard Deviation 2.70
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score
At Last Visit (Participant count=591,198,223,1012)
|
0.20 Units on a scale
Standard Deviation 3.40
|
-0.70 Units on a scale
Standard Deviation 3.50
|
-0.30 Units on a scale
Standard Deviation 3.00
|
-0.10 Units on a scale
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: From Baseline up to 52 WeeksPopulation: The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
Outcome measures
| Measure |
Prior Brexpiprazole
n=591 Participants
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Prior Placebo
n=198 Participants
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
De Novo
n=123 Participants
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
Total
n=1012 Participants
Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
|
|---|---|---|---|---|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score
At Week 26 (Participant count=375,134,123,632)
|
-0.70 Units on a scale
Standard Deviation 2.60
|
-1.50 Units on a scale
Standard Deviation 3.00
|
-0.70 Units on a scale
Standard Deviation 3.40
|
-0.90 Units on a scale
Standard Deviation 2.90
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score
At Week 52 (Participant count=226,93,91,410)
|
-0.90 Units on a scale
Standard Deviation 2.50
|
-2.40 Units on a scale
Standard Deviation 2.90
|
-0.80 Units on a scale
Standard Deviation 3.50
|
-1.20 Units on a scale
Standard Deviation 2.90
|
|
Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score
At Last Visit (Participant count=591,198,223,1012)
|
-0.20 Units on a scale
Standard Deviation 3.20
|
-0.90 Units on a scale
Standard Deviation 3.40
|
-0.40 Units on a scale
Standard Deviation 3.80
|
-0.40 Units on a scale
Standard Deviation 3.40
|
Adverse Events
De Novo (Phase A)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Prior Brexpiprazole (Phase B)
Serious events: 90 serious events
Other events: 166 other events
Deaths: 0 deaths
Prior Placebo (Phase B)
Serious events: 18 serious events
Other events: 53 other events
Deaths: 0 deaths
De Novo (Phase B)
Serious events: 25 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
De Novo (Phase A)
n=226 participants at risk
Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.
NOTE: 12 participants from the trial P33110232 were excluded in this analysis.
|
Prior Brexpiprazole (Phase B)
n=605 participants at risk
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Six participants from the trial P33110231 were excluded in this analysis.
|
Prior Placebo (Phase B)
n=202 participants at risk
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
Participants who received at least 1 dose of study drug were included in this phase.
NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis.
|
De Novo (Phase B)
n=256 participants at risk；n=224 participants at risk
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Five participants from Phase B - Denovo were excluded in this analysis.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
General disorders
Asthenia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.33%
2/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.33%
2/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Infections and infestations
Septic shock
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.50%
1/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.33%
2/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Seizure
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Schizophrenia
|
0.88%
2/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
11.2%
68/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
5.9%
12/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
4.5%
10/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Psychotic disorder
|
0.44%
1/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
1.2%
7/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
1.5%
3/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
1.8%
4/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.89%
2/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Schizophrenia, Paranoid type
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.50%
1/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.50%
1/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.50%
1/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.17%
1/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.44%
1/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.00%
0/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.45%
1/224 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
Other adverse events
| Measure |
De Novo (Phase A)
n=226 participants at risk
Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.
NOTE: 12 participants from the trial P33110232 were excluded in this analysis.
|
Prior Brexpiprazole (Phase B)
n=605 participants at risk
Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Six participants from the trial P33110231 were excluded in this analysis.
|
Prior Placebo (Phase B)
n=202 participants at risk
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
Participants who received at least 1 dose of study drug were included in this phase.
NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis.
|
De Novo (Phase B)
n=256 participants at risk；n=224 participants at risk
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Five participants from Phase B - Denovo were excluded in this analysis.
|
|---|---|---|---|---|
|
Investigations
Weight increased
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
7.8%
47/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
7.4%
15/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
9.0%
23/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
3.6%
22/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
6.9%
14/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
5.5%
14/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
6.9%
42/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
6.9%
14/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
9.4%
24/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
5.0%
30/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
3.5%
7/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
9.0%
23/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
8.4%
51/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
8.4%
17/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
12.5%
32/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/226 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
1.7%
10/605 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
0.99%
2/202 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
7.8%
20/256 • The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER