Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Conditions: Autism
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Approved: 6th December, 2016 
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Summary of protocol for post-marketing surveillance (031-101-00116) 
- Aripiprazole for irritability associated with pediatric autism spectrum disorder (ASD) in Japan 
 
Study Title 
Abilify special-drug-use-results survey (pediatric autism spectrum disorder: oral 
formulations)  
Study Code 
031-101-00116 
Name of Company 
Otsuka Pharmaceutical Co., Ltd. 
Responsible party 
Office of Surveillance Management, Pharmacovigilance Department 
Product Name 
ABILIFY Tablets(Aripiprazole)，ABILIFY Powder(Aripiprazole)，ABILIFY Oral 
Solution(Aripiprazole)，ABILIFY OD Tablets (Aripiprazole) 
Product, Dose  
 
Drug products investigated: 
ABILIFY Tablets 1mg / 3mg /6mg /12mg  
ABILIFY Powder 1% 
ABILIFY Oral Solution 0.1% 
ABILIFY OD Tablets  3mg /6mg /12mg 
Dosage and Administration: 
The usual starting dose in children (from 6 to 17 years old) is 1 mg of 
aripiprazole per day administered. Maintenance dose are from 1mg to 15 mg per 
day are administrated. The dose may be changed for symptom, The fluctuation of 
dose are restricted to 3mg per day. 
Clinical Phase 
IV (non-interventional study) 
Rationale and  
background 
Observational study conducted in Japan is based on the re-examination system and 
not as a condition of the marketing authorization. This kind of non-interventional 
study is generally imposed to all new drugs to quantify the incidence of adverse 
drug reactions (ADRs), and not requested to identify the safety concerns. 
The re-examination system in Japan is defined by the article 14-4 of the 
Pharmaceutical Affairs Law. During a period of re-examination, the MAH plans 
and conducts post-marketing surveys based on GPSP ordinance. In meantime, 
results from post-marketing surveys are reported periodically to PMDA based on 
Periodic Safety Reports (Article 63 of the Enforcement Regulations of the Law). 
Objective 
The purpose of this survey is to identify the following safety and efficacy-related 
questions for an observation period of 1 year with use of oral drug of Abilify in the 
routine clinical setting. 
Study design 
Observational study 
(Multicenter, prospective post-marketing surveillance) 
Data source 
Not applicable (Primary data collection) 

Approved: 6th December, 2016 
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Population 
Pediatric patients in Japan with irritability associated with autism spectrum disorder 
who are planned to be newly started on oral drug of Abilify. 
Sample size 
300 patients 
Study Period 
Study period: April 2017 to September 2019 (30 months) 
Enrollment period: April 2017 to June 2018 (15 months) 
End of Data collection: December 2019 
Primary end point 
For each patient, the observation period is 1 year from the start date of oral drug of 
Abilify. 
For patients who discontinue oral drug of Abilify therapy within 1 year, the 
observation period is to be up to the date of discontinuation of Abilify 
administration. 
Methodology 
Safety information is collected with the procedure described in applicable SOPs.  
Safety Information is defined as “Any information from any source containing 
information such as : 
・Adverse event or suspicion thereof  
・Lack of efficacy 
・Overdose/incorrect dosage (accidental or intentional) 
・Abuse/misuse (e.g. patients sharing medication) – even without resulting adverse 
reaction 
・Accidental exposure (e.g. child takes parent’s medication) 
・Medication error 
・Withdrawal reactions 
・Disease progression/exacerbation of existing disease 
・Drug-drug/Drug-food interactions 
・Exposure to drug during pregnancy, where the embryo or fetus may have been 
exposed to medicinal products (either through maternal exposure or transmission 
of a medicinal product via semen following paternal exposure). 
・Exposure to drug during lactation (including uneventful) 
・Suspected counterfeit product 
・Suspected transfer of infectious disease/agent by the medicinal product concerned. 
･Product Quality Complaint (PQC) with safety related/medically important 
information 
・Pediatric use (if not an approved use) 
・Occupational exposure  
・Off-label use 
Data entry system for original data: PostMaNet (Ver.4) (an electronic data 

Approved: 6th December, 2016 
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capturing system of Fujitsu FIP Corporation) 
Forwards Safety Information from any source to the Local Safety Manager (LSM) 
or appropriate local PV Representative within 24 hours of awareness or the next 
working day in the case of receipt the day prior to or during a weekend, but no later 
than 3 calendar days for reporting to the Global Case Receipt Mailbox.  
Type of CRF: eCRF 
Reconciliation 
The reconciliation of the serious and non-serious AEs between PV database (Argus) 
and study database is going to be performed on a monthly basis and at the end of the 
study. 
Final study report 
The FSR will be finalized within one year of the end of data collection  
(30 December 2020).