Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
Conditions: Tourette's Disorder
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Version 3.0(28Feb2014)                                               1                                                      confidential 
 
Protocol Synopsis  
Name of Sponsor:  Korea Otsuka Pharmaceutical Co., Ltd. 
Name of Investigational Medicinal Product: Aripiprazole 
(Abilify® Tablets/Abilify® ODT) 
Protocol# 
 031-KOA-1101n 
Protocol Title: 
Post-Marketing Surveillance of Safety and Efficacy of 
Abilify® Tablets/Abilify® ODT in Korean Patients with 
Tourette’s Disorder under the “New Drug Re-Examination” 
Clinical Phase: 
Post Marketing Surveillance 
Treatment Indication:  Pediatric patients 6 to 18 years of age with Tourette’s Disorder 
according to the approved product market 
authorization(labeling) 
Objective(s): 
The objective of this surveillance is to evaluate following 
items in relation with use of Abilify® Tablets/Abilify® ODT in 
normal medical practice; 
1. Serious adverse event and adverse drug reaction 
profile 
2. Unexpected adverse event/adverse drug reaction 
profile 
3. Known adverse drug reaction profile 
4. Non-serious adverse drug reaction profile 
5. Other information related to the product safety and 
efficacy 
The hypothesis of this study is that Abilify® Tablets/Abilify® 
ODT is safe and efficacious in the treatment of Korean patients 
with Tourette’s Disorder. 

Version 3.0(28Feb2014)                                               2                                                      confidential 
Trial Design: 
This is a Post-Marketing Surveillance study of Abilify® 
Tablets/Abilify® ODT in accordance with Korean regulations 
on New Drug Re-examination (i.e. New Drug Re-examination 
Standards: MFDS Notification). This study will be conducted 
in a prospective, single-arm, multi-center format. As this study 
is observational in nature, the patient’s follow-up is not 
prescriptive in nature and must be left up to the judgment of 
the physician (investigator), within the period of observation 
set forth in the protocol.  
The protocol will be developed in accordance with the MFDS 
guideline. 
*MFDS : Ministry of Food and Drug Safety 
Trial Population: 
At least 600 patients will be enrolled for surveillance to meet 
the local regulatory requirements. About 50~60 investigators 
across the country will be participating in this surveillance and 
the number of patients to be enrolled by each investigator will 
vary. Among the 600 enrolled patients, it is expected that at 
least 60 patients will enter the long-term surveillance (i.e. 
observation for at least 12 weeks). 

Version 3.0(28Feb2014)                                               3                                                      confidential 
Inclusion/Exclusion 
Criteria: 
Inclusion Criteria 
1. Pediatric patients 6 to 18 years of age with Tourette’s 
Disorder 
2. Patients who are prescribed Abilify® Tablets/Abilify® 
ODT treatment as per investigator’s medical judgment. 
3. Patients who gave written authorization to use their 
personal and health data 
4. Patients 
starting 
Abilify® 
Tablets/Abilify® 
ODT 
treatment after agreement is in place 
Investigators will refer to the product market authorization 
(label) for inclusion criteria. 
Exclusion Criteria 
1. Patients with known hypersensitivity to Aripiprazole  
or any excipients of Abilify® Tablets/Abilify® ODT 
2. Patients who have been treated with Abilify® 
Tablets/Abilify® ODT 
3. Patients with rare hereditary problems of galactose 
intolerance, the lapp lactase deficiency, or glucose-
galactose malabsorption 
4. Patients with score 0(Not assessed) or 1(Normal, not at 
all ill) in the TS-CGI-S 
5. Patients participating in other clinical trial. 
Investigators will refer to the product market authorization 
(label) for exclusion criteria. 
Investigational 
Medicinal Product(s), 
Dose, Dosage 
regimen, Treatment 
period, Formulation, 
Mode of 
Administration: 
Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, 
Abilify® ODT 10mg, 15mg) 
Dosage regimen: Aripiprazole (Abilify® Tablets/Abilify® 
ODT) is being used 2mg/day to 20mg/day as per approved 
marketing authorization (labeling).  
Mode of administration: P.O  

Version 3.0(28Feb2014)                                               4                                                      confidential 
Safety Measures: 
1. Adverse event collection 
2. Others: vital signs (blood pressure and pulse), height, 
weight ,BMI 
Efficacy Measures: 
1) Main surveillance 
Mean change in the TS-CGI from baseline to next visit( at 
least 6 weeks interval  from baseline) post-treatment  
2) Long-term surveillance 
Mean change in the TS-CGI from baseline to next visit( at 
least 12 weeks interval  from baseline) post-treatment  

Version 3.0(28Feb2014)                                               5                                                      confidential 
Statistical Methods: 
Safety analysis set includes all subjects who received Abilify® 
Tablets/Abilify® ODT at least once and followed up for the 
safety evaluation. Efficacy analysis set includes all subjects 
who received Abilify® Tablets/Abilify® ODT for at least 6 
weeks and efficacy evaluation data is available. 
For Long term surveillance, Efficacy analysis set includes all 
subjects who received Abilify® Tablets/Abilify® ODT for at 
least 12 weeks and efficacy evaluation data is available. 
In interim reports, the descriptive statistics for continuous 
variables and frequency (n) and percentage (%) for categorical 
variables will be presented in overall patients.  
In final report (Re-examination report), safety and efficacy 
measures will be summarized and analyzed in overall patients 
and by background factors as well as ADHD patients will 
analyzed separately.  
For continuous variables, the descriptive statistics will be 
presented, and the analysis will be performed using Paired t-
test (in case of Secondary Efficacy Endpoint no.1, One sample 
t-test) or Wilcoxon signed rank test in overall patients and will 
be performed using Two sample t-test(or ANOVA) or 
Wilcoxon rank sum test(or Kruskal-Wallis test) between 
categories of background factors.  
For categorical variables, frequency (n) and percentage(%) 
will be presented, and the analysis will be performed using 
Chi-square test or Fisher’s exact test between categories of 
background factors. Also, 95% confidence interval of 
incidence rate of adverse event will be described. 
Data for special population (i.e. pregnant women, elderly 
patients, patients with liver or renal disease) will be presented 
as well. 

Version 3.0(28Feb2014)                                               6                                                      confidential 
Estimated Duration 
of study 
Planned study schedule as per local regulation is as below; 
1. Estimated regulatory approval on Abilify® indication 
addition: November 2011 
2. Estimated product relaunch date: February 2012 
3. Study period: March 2012 – November 2015 
4. DB reconciliation(clinical DB vs safety DB): 
periodically every 3 months and after completion of 
data collection before writing periodic report or 
reexamination report 
5. Interim reports to MFDS: every 6 months for first 2 
years, then annually thereafter. 
6. Final report to MFDS: within 3 months of study 
completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 3.0(28Feb2014)                                               7                                                      confidential 
 
 
[Appendix]  
 
Management and reporting of safety information  
Procedures for the collection, management and reporting of individual cases of  safety 
information while the study is being conducted, and for the periodic and end of study 
reconciliation of serious/non-serious adverse events between PV database and study 
database, aligned with the current version of G-SOP-ALL-007. 
Definition 
of Safety 
information 
Safety Information as below will be reported in accordance with the current 
Otsuka Global GxP/Pharmacovigilance Glossary. “Any information from 
any source containing information such as 
 
Adverse event or suspicion thereof 
 
Lack of efficacy 
 
Overdose, abuse, misuse (even without resulting adverse reaction) 
 
Medication error 
 
Exposure during pregnancy or lactation (including uneventful) 
 
Counterfeit product 
 
Transfer of infectious disease by the medicinal product concerned 
 
Product complaint report which includes medically important 
information 
 
Pediatric use 
 
Occupational exposure.”