AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
Conditions: Parkinson's Disease
Sponsor: Takeda

 
 
Title: AZILECT Tablets Special Drug Use-Results Survey “Survey on Long-term Safety” 
 
NCT Number: NCT03727139 
Protocol Approve Date: 15-Jan-2021 
 
Certain information within this protocol has been redacted (ie, specific content is 
masked irreversibly from view with a black/blue bar) to protect either personally 
identifiable information or company confidential information. 
 
This may include, but is not limited to, redaction of the following: 
 
Named persons or organizations associated with the study. 
 
Patient identifiers within the text, tables, or figures or in by-patient data listings. 
 
Proprietary information, such as scales or coding systems, which are considered 
confidential information under prior agreements with license holder. 
 
Other information as needed to protect confidentiality of Takeda or partners, 
personal information, or to otherwise protect the integrity of the clinical study. 
 
If needed, certain appendices that contain a large volume of personally identifiable 
information or company confidential information may be removed in their entirety if it 
is considered that they do not add substantially to the interpretation of the data (eg, 
appendix of investigator’s curriculum vitae). 
 
Note; This document was translated into English as the language on original version 
was Japanese. 

 
 
1 
 
 
 
 
 
 
 
 
 
 
Protocol for Special Drug Use-Results Survey 
AZILECT Tablets Special Drug Use-Results Survey 
“Survey on Long- term Safety” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Survey Sponsor 
Takeda Pharmaceutical Company Limited 
Protocol 
Number 
Rasagiline-5001 
Version Number 
Version 4  
Date of 
Preparation 
January 15, 2021 
 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
2 
 
Table of Contents 
1.0 
BACKGROUND ...................................................................................................................................... 1 
2.0 
OBJECTIVES ........................................................................................................................................... 1 
3.0 
SAFETY SPECIFICATION ..................................................................................................................... 1 
4.0 
PLANNED SAMPLE SIZE AND RATIONALE .................................................................................... 1 
4.1 PLANNED SAMPLE SIZE ............................................................................................................................. 1 
4.2 RATIONALE .............................................................................................................................................. 1 
5.0 
PATIENT POPULATION ........................................................................................................................ 3 
5.1 EXCLUSION CRITERIA ............................................................................................................................... 3 
6.0 
DOSAGE AND ADMINISTRATION ..................................................................................................... 3 
7.0 
PLANNED NUMBER OF SURVEY SITES BY SPECIALTY DEPARTMENT .................................. 3 
8.0 
METHODS ............................................................................................................................................... 3 
8.1 DURATION OF OBSERVATION .................................................................................................................... 3 
8.2 SURVEY REQUEST TO MEDICAL INSTITUTIONS AND SURVEY CONTRACT ................................................... 3 
8.3 PATIENT CONSENT .................................................................................................................................... 4 
8.4 PATIENT ENROLLMENT METHODS ............................................................................................................. 4 
8.5 CASE REPORT FORM COMPLETION AND SUBMISSION ................................................................................ 4 
9.0 
PLANNED SURVEY PERIOD ............................................................................................................... 5 
10.0 
SURVEY ITEMS ..................................................................................................................................... 5 
10.1 PATIENT ENROLLMENT ............................................................................................................................. 5 
10.2 PATIENT BACKGROUND ............................................................................................................................ 5 
10.3 TREATMENT DETAILS ............................................................................................................................... 5 
10.4 TREATMENT COMPLIANCE STATUS ........................................................................................................... 6 
10.5 ITEMS OF TESTS AND OBSERVATIONS ....................................................................................................... 6 
10.5.1 Motor symptoms ................................................................................................................ 6 
10.5.2 Other observation items ..................................................................................................... 7 
10.6 ADVERSE EVENTS ..................................................................................................................................... 7 
11.0 
ANALYTICAL ITEMS AND METHODS .............................................................................................. 8 
11.1 DISPOSITION OF PATIENTS ........................................................................................................................ 8 
11.2 PATIENT BACKGROUND ............................................................................................................................ 9 
11.3 TREATMENT DETAILS ............................................................................................................................... 9 
11.4 SAFETY DATA ........................................................................................................................................... 9 
11.4.1 Incidence of adverse events ............................................................................................... 9 
11.4.2 Factors likely affecting the safety ...................................................................................... 9 
11.5 EFFICACY DATA ....................................................................................................................................... 9 
11.5.1 UPDRS Part III total score over time ................................................................................. 9 
11.5.2 Factors likely affecting the efficacy ................................................................................... 9 
12.0 
REGISTRATION OF SURVEY INFORMATION................................................................................ 10 
13.0 
ADMINISTRATIVE STRUCTURE ...................................................................................................... 10 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
3 
 
13.1 SURVEY MANAGER ................................................................................................................................. 10 
14.0 
TRUSTEES ............................................................................................................................................. 10 
15.0 
OTHER NECESSARY ITEMS .............................................................................................................. 10 
15.1 PROTOCOL AMENDMENTS ...................................................................................................................... 10 
15.2 ACTION TO BE TAKEN IN RESPONSE TO DETECTION OF ANY ISSUES OR CONCERNS .................................. 11 
 
 
 
 
 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
1 
 
1.0 
BACKGROUND 
AZILECT Tablets (hereafter referred to as "this drug") has been used overseas for more than 
10 years, and a substantial amount of safety data has been accumulated from the first clinical 
study to post-marketing use. However, safety data collected from Japanese clinical studies are 
limited. 
With this background, this special drug-use results survey (hereinafter referred to as “this 
survey”) has been planned to collect safety information on long-term use of this drug in 
Japanese patients with Parkinson's disease in routine clinical practice and to confirm that the 
safety profile in this survey does not significantly differ from the previously known safety 
profile accumulated inside and outside Japan. 
This survey will be conducted in compliance with the Ministerial Ordinance on Good Post-
Marketing Study Practice (GPSP) and other relevant regulatory requirements. 
 
2.0 
OBJECTIVES 
To evaluate the long-term safety of this drug in patients with Parkinson's disease in daily 
clinical practice and also collect efficacy information.  
 
3.0 
SAFETY SPECIFICATION 
Important identified risks: Orthostatic hypotension, somnolence and sudden onset of sleep, 
psychiatric symptoms such as hallucination, dyskinesia 
 
4.0 
PLANNED SAMPLE SIZE AND RATIONALE 
4.1 
PLANNED SAMPLE SIZE 
1000 patients 
 
4.2 
RATIONALE 
The planned sample size for this survey has been set to 1000 as described below. 
Of the important identified risks of this drug, orthostatic hypotension may be associated with 
trauma from falls when it occurs. Also, somnolence and sudden onset of sleep require caution, 
such as advising patients not to engage in hazardous activities such as driving a car or working 
at heights. Both of “orthostatic hypotension” and “somnolence and sudden onset of sleep” 
require caution in daily living, and thus have been included in the safety variables investigated 
in this survey. 
Also, “psychiatric symptoms such as hallucination” and “dyskinesia” have been included in 
the safety variables investigated in this survey because selegiline, which has a similar 
mechanism of action to this drug, is known to cause hallucination, delusion, etc., likely due to 
co-administration with levodopa, and use of selegiline in combination with levodopa tends to 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
2 
 
exacerbate dyskinesia. 
In a Japanese Phase 3 confirmatory study in patients with early-stage Parkinson's disease (26-
week treatment; Study CCT-001), the incidence of adverse events involving orthostatic 
hypotension was 0.9% (1/117 patients) in the 1 mg group of this drug. Adverse events 
involving hallucination occurred with an incidence of 1.7% (2/117 patients) in the 1 mg group. 
No adverse events involving somnolence or sudden onset of sleep, or dyskinesia were reported. 
In a Japanese phase 2/3 confirmatory study in patients with Parkinson's disease with wearing-
off phenomenon (26-week treatment; Study CCT-002), the incidence of adverse events 
involving orthostatic hypotension in the 1 mg group of this drug was 2.3% (3/129 patients) for 
orthostatic hypotension, 1.6% (2/129 patients) for hypotension, and 0.8% (1/129 patients) for 
blood pressure fluctuation; and the incidence in the 0.5 mg group of this drug was 1.5% (2/133 
patients) for orthostatic hypotension and 0.8% (1/133 patients) for blood pressure decreased. 
The incidence of adverse events involving somnolence or sudden onset of sleep in the 1 mg 
group was 3.1% (4/129 patients) for somnolence and 1.6% (2/129 patients) for sleep attacks, 
and the incidence in the 0.5 mg group was 0.8% (1/133 patients) for somnolence. The 
incidence of adverse events involving hallucination in the 1 mg group was 3.9% (5/129 
patients) for hallucination, 0.8% (1/129 patients) for auditory hallucination, and 0.8% (1/129 
patients) for delirium, and that in the 0.5 mg group was 3.8% (5/133 patients) for hallucination 
and 1.5% (2/133 patients) for visual hallucination. Adverse events of dyskinesia occurred in 
16.3% (21/129 patients) in the 1 mg group and 8.3% (11/133 patients) in the 0.5 mg group. 
In the Japanese phase 3, long-term extension study in patients with early-stage Parkinson's 
disease (26-week extension after 26-week treatment in CCT-001: Study OCT-001), the 
incidence of adverse events involving orthostatic hypotension was 0.9% (1/117 patients) for 
orthostatic hypotension in the patients allocated to the 1 mg group of this drug in Study CCT-
001. The incidence of adverse events involving somnolence or sudden onset of sleep was 1.7% 
(2/117 patients) for somnolence in the patients allocated to the 1 mg group of this drug in 
Study CCT-001. The incidence of adverse events involving hallucination was 1.7% (2/117 
patients) for hallucination and 0.9% (1/117 patients) for visual hallucination in the patients 
allocated to the 1 mg group in Study CCT-001, and 1.1% (1/95 patients) for hallucination and 
1.1% (1/95 patients) for visual hallucination in the patients allocated to placebo in Study CCT-
001. Dyskinesia was not observed. 
In the Japanese phase 3, long-term study of this drug in combination with levodopa (52-week 
treatment; Study OCT-002), the incidence of adverse events involving orthostatic hypotension 
was 5.4% (12/222 patients) for orthostatic hypotension, 0.9% (2/222 patients) for hypotension, 
and 0.9% (2/222 patients) for blood pressure decreased. The incidence of adverse events 
involving somnolence or sudden onset of sleep was 1.4% (3/222 patients) for somnolence and 
0.5% (1/222 patients) for sleep attacks. The incidence of adverse events involving 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

3 
hallucination was 3.2% (7/222 patients) for hallucination, 1.4% (3/222 patients) for visual 
hallucination, 0.9% (2/222 patients) for delirium, 0.5% (1/222 patients) for illusion, and 0.5% 
(1/222 patients) for disorientation. The incidence of adverse events of dyskinesia was 10.8% 
(24/222 patients). 
In light of these data, the planned sample size for this survey has been set to 1000. Assuming 
that orthostatic hypotension, somnolence and sudden onset of sleep, psychiatric symptoms 
such as hallucination, and dyskinesia would occur with an incidence of 1% or above, the 
planned sample size of 1000 will enable evaluation of these events to a certain extent. With a 
sample size of 1000, at least 5 cases of an adverse event occurring with an incidence of 1.0% 
can be detected with a probability of at least 95%. 
5.0 
PATIENT POPULATION 
This survey will be conducted in patients with Parkinson's disease, excluding those meeting 
the exclusion criteria below. The precautions in the package insert for AZILECT should also 
be referenced. 
5.1 
EXCLUSION CRITERIA 
Patients who meet the following criterion will be excluded from this survey. 
Patients with any contraindication for this drug 
6.0 
DOSAGE AND ADMINISTRATION 
The usual adult dosage of rasagiline is 1 mg orally once daily. The precautions in the package 
insert for AZILECT should also be referenced. 
7.0 
PLANNED NUMBER OF SURVEY SITES BY SPECIALTY DEPARTMENT 
Neurology department etc. 
Approximately 100 sites 
8.0 
METHODS 
8.1 
DURATION OF OBSERVATION 
12 months 
For patients enrolled during the first 12 months of the survey, the maximum duration of 
observation will be 24 months, in accordance with the patient enrollment period (24 months). 
If administration of this drug is discontinued for any reason, the survey will be terminated at 
that time. 
8.2 
SURVEY REQUEST TO MEDICAL INSTITUTIONS AND SURVEY CONTRACT 
For the conduct of this survey, a representative of Takeda Pharmaceutical Company Limited 
(hereinafter referred to as Takeda representative) will enter into a written contract with the 
medical institution. 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
4 
 
 
8.3 
PATIENT CONSENT 
Before patient enrollment, the survey physician will explain the contents of the informed 
consent form to the patients (or their legally acceptable representatives) and obtain verbal or 
written consent from the patients (or their legally acceptable representatives) to permit data 
provision for the survey. 
For written consent, the patient (or his/her legally acceptable representative) will sign and 
date the informed consent form. The survey physician shall retain the original signed 
informed consent form. 
The informed consent form shall include an overview of the survey, handling of the patient's 
personal information and personal medical information in the survey, and a statement that 
the patient is free to discontinue participation in the survey at any time without giving a 
reason and without any disadvantages in treatment. 
Patients who have provided consent will be assigned identification numbers. 
 
8.4 
PATIENT ENROLLMENT METHODS 
Patients will be enrolled using a "centralized enrollment method” via a web-based electronic 
data collection system (Rave EDC). 
The survey physician or designee will enter data for patient enrollment into the Rave EDC 
system by 14 days after the date of prescription of this drug (with the day of prescription 
defined as "day 0" and the next day as "day 1"), and affix an electronic signature. 
 
8.5 
CASE REPORT FORM COMPLETION AND SUBMISSION 
The Rave EDC system will be used to collect information. 
For all enrolled patients, the survey physician or designee will enter data into the Rave EDC 
system promptly after the end of the observation period of individual patients, and the survey 
physician will affix an electronic signature. If administration of this drug cannot be confirmed, 
this fact should be entered (no other items need to be entered). 
For patients with discontinuation of treatment with this drug during the observation period for 
any reason, the survey physician or designee will enter data into the Rave EDC system 
promptly after completion of necessary observations, and the survey physician will affix an 
electronic signature. However, for patients with occurrence of an adverse event leading to 
discontinuation of treatment with this drug, the survey physician will continue observation of 
the patient even after treatment discontinuation until the event outcome of “Resolved” or 
“Resolving” wherever possible. The survey physician or designee will then enter the 
observation results into the Rave EDC system, and the survey physician will affix an electronic 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
5 
 
signature. 
 
9.0 
PLANNED SURVEY PERIOD 
Survey period: November 2018 to October 31, 2021 
Patient enrollment period: November 2018 to October 31, 2020Note) 
 
Note) No patient can be enrolled (data entry into the Rave EDC system) on and after November 
1, 2020, even if this drug is prescribed to the patient by October 31, 2020. 
If the total number of enrolled patients in this survey reached the planned sample size before 
October 31, 2020, enrolment of patients will be terminated even before the end of the 
patient enrollment period. If the patient enrollment period is shortened, the survey period 
will be shortened according to the shortened duration. 
 
10.0 
SURVEY ITEMS 
For the following items, the survey physician or designee will enter data into the Rave EDC 
system. The survey schedule is shown in Appendix 1. 
 
10.1 PATIENT ENROLLMENT 
1) Survey items 
Date of prescription of this drug, patient identification number, patient initials, sex, age (at 
the time of prescription of this drug), and assessment against the exclusion criteria 
2) Time of data collection 
At enrollment of the patient 
 
10.2 PATIENT BACKGROUND 
1) Survey items 
Time of onset of Parkinson's disease, inpatient/outpatient status (at the start of treatment 
with this drug), concurrent diseases (presence or absence and details), height, body 
weight, history of smoking, modified Hoehn & Yahr Severity scale stage, presence or 
absence of wearing-off phenomenon (in patients given levodopa at the time of 
administration of this drug), and presence or absence of dyskinesia (in patients given 
levodopa at the time of administration of this drug). 
2) Time of data collection 
At initiation of treatment with this drug 
 
10.3 TREATMENT DETAILS 
1) Survey items 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
6 
 
Detailed use of this drug (dosage*, therapy dates, reason for discontinuation), detailed use 
of levodopa (presence or absence, dosage, therapy dates), detailed use of drugs to treat 
Parkinson's disease other than this drug and levodopa (presence or absence, name of the 
drug, therapy dates), detailed use of concomitant drugs other than drugs to treat 
Parkinson's disease (presence or absence, name of the drug, reason for use), detailed use 
of concomitant therapies other than pharmacotherapy for Parkinson's disease (presence or 
absence, name of concomitant therapy, therapy dates). 
*If the daily dose is not 0.5 mg or 1 mg, any occurrence of adverse events due to overdose should be 
specified. If the starting daily dose is not 1 mg, the reason should be specified. 
2) Time of data collection 
From initiation of treatment with this drug until 12 months (or discontinuation) of 
treatment with this drug 
For patients enrolled during the first 12 months of the survey, however, data will be 
collected up to 24 months (or discontinuation) of treatment. 
 
10.4 TREATMENT COMPLIANCE STATUS 
1) Survey items 
Status of treatment compliance with this drug* 
*Criteria for treatment compliance assessment 
 
1. ≥90% (Nearly all of the doses were taken as prescribed.) 
2. ≥70% (Doses were taken as prescribed on at least 5 days a week.) 
3. ≥50% dose (Doses were taken as prescribed on at least 4 days a week.) 
4. <50% (Doses were taken as prescribed on 1–3 days a week.) 
5. No doses were taken, or treatment compliance was unknown. 
2) Time of data collection 
At 6 months, 12 months, 18 months*, and 24 months* (or discontinuation) of treatment 
with this drug 
*For patients observed for 24 months 
 
10.5 ITEMS OF TESTS AND OBSERVATIONS 
Data from tests and observations performed in the routine clinical setting will be 
collected, using the time indicated under “Time of data collection” as a guide. 
10.5.1 Motor symptoms 
1) Test items 
Unified Parkinson's Disease Rating Scale (UPDRS) Part III 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
7 
 
2) Time of data collection 
At initiation of treatment with this drug, 6 months, 12 months, 18 months*, and 24 
months* (or discontinuation) of treatment with this drug (if the test is performed) 
*For patients observed for 24 months 
10.5.2 Other observation items 
1) Observation items 
Presence or absence of pregnancy during the observation period (females only) 
2) Time of data collection 
From initiation of treatment with this drug until 12 months (or discontinuation) of 
treatment with this drug 
For patients enrolled during the first 12 months of the survey, however, data will be 
collected up to 24 months (or discontinuation) of treatment. 
 
10.6 ADVERSE EVENTS 
1) Survey items 
Presence or absence of adverse events (see Table 1), adverse event term, date of onset, 
seriousness and reason for the assessment as serious (see Table 2), action taken with this 
drug, outcome assessment date, outcome, causal relationship to this drug* (see Table 3), 
laboratory test values over time** 
If the event outcome is “Not resolved” or “Unknown”, the event should be followed as far 
as possible. 
*If the causal relationship to this drug is “Not related”, the basis for the assessment should be 
collected. 
**Collected if there is any adverse event involving abnormal laboratory values. 
Note) Special guidance on reporting of adverse events: 
Abnormal worsening of the target disease, such as aggravation outside the predictable range of the 
natural course of the disease, should be handled as an adverse event. 
2) Time of data collection 
From initiation of treatment with this drug until 12 months (or discontinuation) of 
treatment with this drug 
For patients enrolled during the first 12 months of the survey, however, data will be 
collected up to 24 months (or discontinuation) of treatment. 
 
 
 
 
 
Table 1 Definition of adverse events 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
8 
 
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical 
product and which does not necessarily have a causal relationship with this treatment.  
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, 
whether or not the event is considered causally related to the use of the product. 
 
Table 2 Criteria for serious adverse events 
An adverse event is serious if it:  
1. results in death (Death) 
2. is life -threatening (Life-threatening) 
The term “life-threatening” refers to an event in which the patient was at risk of death at the time of 
the event. It does not refer to an event that hypothetically might have caused death if it were more 
severe. 
3. requires hospitalization or prolongation of existing hospitalization (Hospitalization/Prolongation of 
hospitalization) 
4. results in persistent or significant disability/incapacity (Disability) 
5. leads to a congenital anomaly or birth defect (Congenital anomaly) 
6. is a medically important event (which may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the patient or may require intervention to prevent outcomes 1 to 5 
above) 
Note) Any reported adverse events consistent with the “Takeda Medically Significant AE List” will also be 
handled as serious adverse events by Takeda Pharmaceutical Company Limited. 
 
Table 3 Assessment criteria for adverse event causality to this drug  
Causality 
classification 
Assessment Criteria 
Related 
An adverse event that follows a temporal sequence from administration of this drug 
(including the course after withdrawal of the drug), or for which there is at least 
reasonable possibility of involvement of this drug and its causal role cannot be ruled 
out, although factors other than the drug, such as the primary disease, concurrent 
diseases, concomitant drugs or concurrent treatments, may also be responsible. 
Not related 
An adverse event that does not follow a temporal sequence from administration of this 
drug or that can reasonably be explained by other factors, such as the primary disease, 
concurrent diseases, concomitant drugs or concurrent treatments. 
 
11.0 
ANALYTICAL ITEMS AND METHODS 
 
11.1 DISPOSITION OF PATIENTS 
Number of patients enrolled in the survey, number of patients with collected case report forms 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
9 
 
(CRFs), numbers of patients evaluated for safety and efficacy, number of patients excluded 
from evaluations and reason for exclusion etc. will be tabulated. 
 
11.2 PATIENT BACKGROUND 
Patient background data, such as sex, age, duration of disease, and concurrent diseases, will 
be tabulated. 
 
11.3 TREATMENT DETAILS 
Detailed use of this drug, treatment compliance status, and detailed use of concomitant drugs 
will be tabulated. 
 
11.4 SAFETY DATA 
The following data will be tabulated using the safety analysis population. Adverse events will 
be coded using the MedDRA/J, and summarized by Preferred Term (PT) and System Organ 
Class (SOC). 
 
11.4.1 Incidence of adverse events 
Adverse events occurring during the observation period will be summarized using 
frequency tabulation by event type, time to onset, seriousness, causal relationship to this 
drug, etc. 
 
11.4.2 Factors likely affecting the safety 
Adverse drug reactions occurring during the observation period will be summarized using 
frequency tabulation, with stratification of patients according to background factors (e.g., 
sex, age, presence or absence of concurrent renal disorder, presence or absence of 
concurrent hepatic disorder) and detailed use of this drug. 
 
11.5 EFFICACY DATA 
The following data will be tabulated using the efficacy analysis set. 
 
11.5.1 UPDRS Part III total score over time 
The UPDRS Part III total score at each time point of the test and the changes (post-
baseline score at respective time point − baseline score) will be tabulated. 
 
11.5.2 Factors likely affecting the efficacy 
The change from baseline in UPDRS Part III total score will be tabulated, with 
stratification of patients according to background factors (e.g., duration of Parkinson's 
disease, modified Hoehn & Yahr Severity scale stage), detailed use of drugs to treat 
Parkinson's disease, etc. 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
10 
 
 
12.0 
REGISTRATION OF SURVEY INFORMATION 
Before initiation of this survey, information on this survey will be registered with the following 
public websites: 
• Japan Pharmaceutical Information Center (JAPIC) Clinical Trials Information: Japan Pharmaceutical 
Information Center- 
Clinical Trials 
Information 
• National Institutes of Health Clinical Trial Registration System: ClinicalTrials.gov 
 
 
13.0 
ADMINISTRATIVE STRUCTURE 
13.1 SURVEY MANAGER 
GPSP Officer, Takeda Pharmaceutical Company Limited 
 
 
14.0 
TRUSTEES 
(1) EPS Corporation 
Address: 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo 
Activities: Rave EDC system construction and statistical analysis activities 
 
(2) PRA Health Sciences K.K. 
Address: 4-1-3 Kyutaromachi, Chuo-ku, Osaka 
Activities: Supporting activities in data management, record archiving activities, 
adverse event report conversion to PDF, and dissemination of 
information 
 
 
 
(3) PharField Corporation 
Address: 2-8-20 Saga, Koto-ku, Tokyo 
Activities: Monitoring-related activities 
 
15.0 
OTHER NECESSARY ITEMS 
15.1 PROTOCOL AMENDMENTS 
During the survey period, monitoring will be performed regarding the progress of the survey, 
occurrence of adverse drug reactions unexpected from the precautions and serious adverse 
drug reactions, any increase in the incidence of particular adverse drug reactions, validity of 
the survey items etc., and the protocol will be reviewed and amended as necessary. If any 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
11 
 
partial change to the DOSAGE AND ADMINISTRATION, INDICATIONS, etc. is approved 
during the survey period, whether or not the protocol should be amended will be examined, 
and the protocol will be amended as necessary. 
 
15.2 ACTION TO BE TAKEN IN RESPONSE TO DETECTION OF ANY ISSUES OR CONCERNS 
Whenever an issue is found regarding the safety or efficacy, the data will be investigated in 
detail, and necessary actions will be determined. 
 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

 
 
12 
 
Appendix 1 Observation Schedule 
 
Time of data collection 
 
 
Survey items 
Observation period 
At enrollment of 
the patient 
Start of treatment 
6 months 
 
12 months 
18 months 
* 
24 months 
* 
Discontinuation 
of treatment 
Patient 
enrollment 
Date of prescription of this drug 
○ 
 
 
 
 
 
 
Patient identification number 
○ 
 
 
 
 
 
 
Patient initials 
○ 
 
 
 
 
 
 
Sex 
○ 
 
 
 
 
 
 
Age 
○ 
 
 
 
 
 
 
Exclusion criteria assessment 
○ 
 
 
 
 
 
 
Patient 
background 
Time of onset of Parkinson's disease 
 
○ 
 
 
 
 
 
Inpatient/outpatient status 
 
○ 
 
 
 
 
 
Concurrent diseases 
 
○ 
 
 
 
 
 
Height, body weight 
 
○ 
 
 
 
 
 
Smoking history 
 
○ 
 
 
 
 
 
Modified Hoehn & Yahr Severity 
scale 
 
○ 
 
 
 
 
 
Presence or absence of wearing-off 
phenomenon** 
 
○ 
 
 
 
 
 
Presence or absence of dyskinesia** 
 
○ 
 
 
 
 
 
Treatment 
details 
Detailed use of this drug 
 
←○→ 
←○→ 
○ 
Detailed use of levodopa 
 
←○→ 
←○→ 
○ 
Detailed use of drugs to treat 
Parkinson's disease other than this 
drug and levodopa 
 
←○→ 
←○→ 
○ 
Detailed use of concomitant drugs 
(other than drugs to treat Parkinson's 
disease) 
 
←○→ 
←○→ 
○ 
Detailed use of concomitant therapies 
other than pharmacotherapy for 
Parkinson's disease 
 
←○→ 
←○→ 
○ 
Status of treatment compliance with 
this drug 
 
 
○ 
○ 
○ 
○ 
○ 
Observation 
items 
UPDRS Part III 
 
○ 
○ 
○ 
○ 
○ 
○ 
Any pregnancy (females only) 
 
←○→ 
←○→ 
○ 
Adverse events 
 
←○→ 
←○→ 
○ 
*For patients observed for 24 months 
**: Investigated in patients given levodopa at the time of administration of this drug 
○             : Performed in routine clinical practice 
○             : Performed in routine clinical practice throughout this period 
 
 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use