Trial Outcomes & Findings for A Long-term Trial of OPC-34712 in Patients With Schizophrenia (NCT NCT01456897)

NCT ID: NCT01456897

Last Updated: 2019-12-30

Results Overview

A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 282 participants
• Primary outcome timeframe: From Baseline up to 52 Weeks
• Results posted on: 2019-12-30

Participant Flow

Participant milestones

Measure	New Subjects 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 this trial	Rollover Subjects Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Overall Study STARTED	184	98
Overall Study COMPLETED	109	41
Overall Study NOT COMPLETED	75	57

Reasons for withdrawal

Measure	New Subjects 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 this trial	Rollover Subjects Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Overall Study Adverse Event	19	22
Overall Study Protocol Violation	3	4
Overall Study Physician Decision	5	3
Overall Study Withdrawal by Subject	44	17
Overall Study Lack of Efficacy	4	11

Baseline Characteristics

A Long-term Trial of OPC-34712 in Patients With Schizophrenia

Baseline characteristics by cohort

Measure	New Subjects n=184 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 this trial	Rollover Subjects n=98 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial	Total n=282 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	155 Participants n=5 Participants	98 Participants n=7 Participants	253 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	0 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	45.5 years STANDARD_DEVIATION 14.7 • n=5 Participants	42.5 years STANDARD_DEVIATION 12.5 • n=7 Participants	44.4 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	58 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	40 Participants n=7 Participants	130 Participants n=5 Participants
Region of Enrollment Japan	184 participants n=5 Participants	98 participants n=7 Participants	282 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to 52 Weeks

Population: Safety sample included those participants who had treated IMP.

A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment.

Outcome measures

Measure	New Subjects n=183 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 this trial	Rollover Subjects n=98 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Percentage of Participants With Adverse Events Treatment-Emergent Adverse Events (TEAE)	156 Participants	79 Participants
Percentage of Participants With Adverse Events Potentially Drug-related TEAE	95 Participants	38 Participants
Percentage of Participants With Adverse Events Death	0 Participants	0 Participants
Percentage of Participants With Adverse Events SAE	19 Participants	18 Participants
Percentage of Participants With Adverse Events Severe Treatment-Emergent Adverse Event	8 Participants	7 Participants
Percentage of Participants With Adverse Events Discontinued Due to Adverse Events	20 Participants	23 Participants

SECONDARY outcome

Timeframe: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

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 ranged from 7 (best possible outcome) to 210 (worst possible outcome).

Outcome measures

Measure	New Subjects n=182 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 this trial	Rollover Subjects n=97 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Week24	-5.31 units on a scale Standard Deviation 9.00	-7.20 units on a scale Standard Deviation 12.59
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Week52	-7.01 units on a scale Standard Deviation 10.56	-9.44 units on a scale Standard Deviation 15.16
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Last Visit	-3.11 units on a scale Standard Deviation 12.76	-2.58 units on a scale Standard Deviation 15.56

SECONDARY outcome

Timeframe: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

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 PANSS positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).

Outcome measures

Measure	New Subjects n=182 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 this trial	Rollover Subjects n=97 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Mean Change From Baseline in PANSS Positive Subscale Score WEEK24	-1.09 units on a scale Standard Deviation 2.27	-1.53 units on a scale Standard Deviation 3.40
Mean Change From Baseline in PANSS Positive Subscale Score WEEK52	-1.13 units on a scale Standard Deviation 2.73	-1.61 units on a scale Standard Deviation 4.41
Mean Change From Baseline in PANSS Positive Subscale Score Last Visit	-0.19 units on a scale Standard Deviation 3.96	0.24 units on a scale Standard Deviation 4.83

SECONDARY outcome

Timeframe: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

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 PANSS 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. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).

Outcome measures

Measure	New Subjects n=182 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 this trial	Rollover Subjects n=97 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Mean Change From Baseline in PANSS Negative Subscale Score Week24	-1.64 units on a scale Standard Deviation 3.22	-1.49 units on a scale Standard Deviation 3.84
Mean Change From Baseline in PANSS Negative Subscale Score Week52	-2.27 units on a scale Standard Deviation 3.85	-2.02 units on a scale Standard Deviation 4.47
Mean Change From Baseline in PANSS Negative Subscale Score Last Visit	-1.43 units on a scale Standard Deviation 3.85	-0.89 units on a scale Standard Deviation 3.92

SECONDARY outcome

Timeframe: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 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	New Subjects n=182 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 this trial	Rollover Subjects n=97 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Week24	-0.26 units on a scale Standard Deviation 0.71	-0.20 units on a scale Standard Deviation 0.75
Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Week52	-0.28 units on a scale Standard Deviation 0.67	-0.15 units on a scale Standard Deviation 0.82
Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Last Visit	-0.13 units on a scale Standard Deviation 0.81	0.03 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Population: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of study medication. 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	New Subjects n=182 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 this trial	Rollover Subjects n=97 Participants Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Mean Clinical Global Impression - Global Improvement(CGI-I) Week24	3.09 units on a scale Standard Deviation 0.94	3.16 units on a scale Standard Deviation 0.90
Mean Clinical Global Impression - Global Improvement(CGI-I) Week52	3.09 units on a scale Standard Deviation 0.91	3.22 units on a scale Standard Deviation 0.99
Mean Clinical Global Impression - Global Improvement(CGI-I) Last Visit	3.48 units on a scale Standard Deviation 1.22	3.86 units on a scale Standard Deviation 1.27

Adverse Events

New Subjects

Serious events: 19 serious events

Other events: 112 other events

Deaths: 0 deaths

Rollover Subjects

Serious events: 18 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	New Subjects n=183 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 this trial	Rollover Subjects n=98 participants at risk Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Infections and infestations Meningitis aseptic	0.00% 0/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Injury, poisoning and procedural complications Heat illness	0.00% 0/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Metabolism and nutrition disorders Dehydration	0.55% 1/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Akathisia	0.55% 1/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	1.0% 1/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Extrapyramidal disorder	0.55% 1/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	0.00% 0/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Psychiatric disorders Schizophrenia	9.3% 17/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	13.3% 13/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term

Other adverse events

Measure	New Subjects n=183 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 this trial	Rollover Subjects n=98 participants at risk Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
Gastrointestinal disorders Diarrhoea	5.5% 10/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	3.1% 3/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Infections and infestations Nasopharyngitis	25.1% 46/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	19.4% 19/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Investigations Weight increased	4.9% 9/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	10.2% 10/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Musculoskeletal and connective tissue disorders Back pain	7.1% 13/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	4.1% 4/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Akathisia	8.2% 15/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	7.1% 7/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Headache	10.4% 19/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	3.1% 3/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Somnolence	7.1% 13/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	3.1% 3/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Nervous system disorders Tremor	2.2% 4/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	8.2% 8/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Psychiatric disorders Schizophrenia	11.5% 21/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	13.3% 13/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Psychiatric disorders Insomnia	8.2% 15/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	2.0% 2/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
Skin and subcutaneous tissue disorders Eczema	2.7% 5/183 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term	6.1% 6/98 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks). Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., Ltd.

Email: CL_OPCJ_RDA_Team@otsuka.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place