Special Drug Use Surveillance for Adcetris Intravenous Infusion 50 Milligrams "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Hodgkin Lymphoma (Only Pediatric Patients)"
Conditions: Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Sponsor: Takeda

 
 
Clinical Study Protocol 
 
NCT Number: NCT04213209 
Title: Specified drug use Surveillance for ADCETRIS Intravenous Infusion 50 mg 
"Relapsed or refractory CD30 positive peripheral T-cell lymphoma and Hodgkin 
lymphoma (pediatric only)" 
Study Number: C25021 
Document Version and Date: Version 7.0 / 12-Sep-2023 
 
Certain information within this document has been redacted (ie, specific content is 
masked irreversibly from view) to protect either personally identifiable information or 
company confidential information. 
 
A summary of changes to previous protocol versions is appended to the end of the 
document. 
 
Note; This document was translated into English as the language on original version 
was Japanese. 

Special drug use Surveillance protocol 
Specified drug use Surveillance for ADCETRIS 
Intravenous Infusion 50 mg  
"Relapsed or refractory CD30 positive peripheral T-
cell lymphoma and Hodgkin lymphoma (pediatric 
only)" 
Investigation 
sponsor 
Takeda Pharmaceutical Co., Ltd. 
Protocol number
C25021 
Version Number
Version 7.0 
Date of 
preparation 
Sep.12, 2023
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use

Table of Contents
1.0 
BACKGROUND OF IMPLEMENTATION ............................................................................................ 1 
2.0 
OBJECTIVE ............................................................................................................................................. 1 
3.0 
SAFETY SPECIFICATION ..................................................................................................................... 1 
4.0 
SCHEDULED SAMPLE SIZE AND BASIS FOR SETTING ................................................................ 1 
4.1 PLANNED SAMPLE SIZE ............................................................................................................................. 1 
4.2 RATIONALE .......................................................................................................................................... 2 
5.0 
PATIENTS TO BE SURVEYED ............................................................................................................. 2 
5.1 SELECTION CRITERIA ................................................................................................................................ 2 
5.2 EXCLUSION CRITERIA ............................................................................................................................... 2 
6.0 
DOSAGE AND ADMINISTRATION ..................................................................................................... 2 
7.0 
NUMBER OF MEDICAL INSTITUTIONS BY PLANNED CLINICAL DEPARTMENT................... 3 
8.0 
METHODS ............................................................................................................................................... 3 
8.1 OBSERVATION PERIOD .............................................................................................................................. 3 
8.2 REQUEST AND CONTRACT FOR MEDICAL INSTITUTIONS ............................................................................ 3 
8.3 PATIENT'S CONSENT ................................................................................................................................. 3 
8.4 HOW TO ENROLL PATIENTS ....................................................................................................................... 4 
8.5 PREPARATION AND SUBMISSION OF SURVEY FORMS ................................................................................. 4 
9.0 
DURATION OF THE PROJECT ............................................................................................................. 5 
10.0 
EXAMINATIONS AND OBSERVATIONS ........................................................................................... 5 
10.1 PATIENT ENROLLMENT ............................................................................................................................. 5 
10.2 PATIENT CHARACTERISTICS ..................................................................................................................... 5 
10.3 TREATMENT OF PTCL OR HL PRIOR TO INITIATION OF DRUG TREATMENT ............................................... 6 
10.4 TREATMENT ............................................................................................................................................. 6 
10.5 BENEFICIAL AGAINST COLORECTAL ......................................................................................................... 6 
10.6 LAST DAY OF OBSERVATION ..................................................................................................................... 7 
10.7 OTHER OBSERVATIONS ............................................................................................................................. 7 
10.8 ADVERSE EVENTS ..................................................................................................................................... 7 
11.0 
ANALYSIS ITEMS AND METHODS .................................................................................................... 8 
11.1 ITEMS RELATED TO CASE COMPOSITION ................................................................................................... 8 
11.2 PATIENT CHARACTERISTICS ..................................................................................................................... 8 
11.3 TREATMENT ............................................................................................................................................. 9 
11.4 SAFETY ISSUES ......................................................................................................................................... 9 
11.4.1 Incidence of adverse events ............................................................................................... 9 
11.4.2 Factors that may affect safety ............................................................................................ 9 
11.5 ITEMS RELATED TO EFFICACY ................................................................................................................... 9 
11.5.1 Antitumor effects (Best Response) .................................................................................... 9 
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11.5.2 Overall survival .................................................................................................................. 9 
12.0 
REGISTRATION OF SURVEY INFORMATION.................................................................................. 9 
13.0 
ORGANIZATIONAL STRUCTURE..................................................................................................... 10 
13.1 MANAGEMENT REPRESENTATIVE ........................................................................................................... 10 
13.2 MEDICAL ADVISOR ................................................................................................................................. 10 
14.0 
CONTRACT RESEARCH ORGANIZATION ...................................................................................... 10 
15.0 
ADDITIONAL ACTIONS THAT MAY BE TAKEN BASED ON THE RESULTS OF THE 
INVESTIGATION.............................................................................................................................................. 10 
16.0 
IMPLEMENTATION STATUS OF THE INVESTIGATION, TIME OF MILESTONE 
ASSESSMENT OR REPORTING ..................................................................................................................... 10 
17.0 
OTHER REQUIRED ITEMS. ................................................................................................................ 10 
17.1 PROTOCOL AMENDMENT ........................................................................................................................ 10 
17.2 MEASURES TO BE TAKEN IN THE EVENT THAT PROBLEMS OR QUESTIONS ARE IDENTIFIED ..................... 11 
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1.0 
BACKGROUND OF IMPLEMENTATION 
ADCETRIS® intravenous injection 50mg (drug) has been confirmed to be safe and effective 
in the post-marketing period for indications of relapsed or refractory CD30 positive Hodgkin 
Lymphoma (hereafter HL) or undifferentiated large-cell Lymphoma (hereafter ALCL) in 
adults. On the other hand, there is little information on the safety of this product in Japanese 
patients with relapsed or refractory peripheral T-cell lymphomas (PTCL) who are CD30 
positive other than ALCL. There are also limited data available from clinical studies in 
pediatric patients with relapsed or refractory CD30 positive PTCL or HL-HL. Therefore, the 
safety of drug should be confirmed in adult patients with relapsed or refractory CD30 positive 
PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30 positive 
PTCL or HL in routine clinical practice after obtaining approvals for the indication of CD30 
positive PTCL in drug, and the safety should be appropriately communicated to healthcare 
professionals. This survey was therefore planned. 
This survey will be conducted in compliance with GPSP ordinances and other relevant 
regulatory requirements. 
2.0 
OBJECTIVE 
To evaluate the safety of the safety parameters included in this survey in adult patients with 
relapsed or refractory CD30 positive PTCL (excluding ALCL) and pediatric patients with 
relapsed or refractory CD30 positive PTCL or HL in routine clinical practice. 
The following items are examined. 
・Peripheral neuropathy: Confirmation of the status of onset (incidence, seriousness, time
of onset, etc.), drug dose-adjustment status, and effects of background factors
・Myelosuppression (neutropenia): Confirmation of the occurrence of myelosuppression
(incidence, seriousness, time of onset, etc.), drug dose-adjustment status, and effects of
background factors
・Lung disorders: Confirmation of the effects of the event (incidence, seriousness, time of
onset, etc.) and patient demographic factors
3.0 
SAFETY SPECIFICATION 
Peripheral neuropathy, myelosuppression (neutropenia), pulmonary disorder 
4.0 
SCHEDULED SAMPLE SIZE AND BASIS FOR SETTING 
4.1 
PLANNED SAMPLE SIZE 
Adults (18 years of age or older at the start of treatment): 
80 patients with relapsed or refractory CD30 positive PTCL (excluding ALCL) 
(as a safety analysis set) 
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Children (aged <18 years at the start of treatment): 
Six patients with relapsed or refractory CD30 positive PTCL or HL 
(as a safety analysis set) 
4.2 
RATIONALE FOR SAMPLE SIZE
Among the events specified as safety specifications in this survey (peripheral neuropathy, 
myelosuppression (neutropenia), and pulmonary disorder), the most frequently reported 
adverse event in the special drug use surveillance in patients with relapsed or refractory CD30 
positive HL and ALCL was febrile neutropenia (3.87%). Therefore, since 76 cases are required 
to observe this event in at least 1 case with a probability of 95% or more, the number of 
subjects collected in the adult survey was set at 80 cases. The number of cases of recurrent or 
refractory HL patient and PTCL patient of the child was estimated to be about 10 cases per 
year, and the planned number of cases of the child was set to 6 in consideration of investigation 
period, expected prescription of Adcetris, etc.. 
5.0 
PATIENTS TO BE SURVEYED 
The study is conducted in adult patients with PTCL (excluding ALCL) and pediatric patients 
with PTCL or HL. However, the following inclusion criteria and exclusion criteria shall not 
be met. 
Refer to the package insert. 
5.1 
SELECTION CRITERIA 
Patients are eligible for the study if they meet the following criteria: 
①Patients with relapsed or refractory disease
②CD30 positive patients
③Patients who receive drug after obtaining approval for the indication of PTCL
5.2 
EXCLUSION CRITERIA 
Patients who meet the following criteria are not eligible. 
①Patients with a history of severe hypersensitivity to any ingredient of the product
②Patients receiving bleomycin hydrochloride
6.0 
DOSAGE AND ADMINISTRATION 
The usual dosage is 1.8 mg/kg (body weight) of brentuximab Vedotin (Genetical 
Recombination) administered as an intravenous drip infusion once every 3 weeks. The dose 
may be decreased according to the patient's condition. 
For details, refer to the package insert. 
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7.0 
NUMBER OF MEDICAL INSTITUTIONS BY PLANNED CLINICAL DEPARTMENT 
About 80 medical institutions, including hematology and pediatrics, and about 6 medical 
institutions 
  
 
8.0 
METHODS 
8.1 
OBSERVATION PERIOD 
12 months from the initiation of drug treatment (until that time for discontinued or dropout 
patients) 
Note) For patients who started Adcetris on or after July 1, 2022, the observation period will 
be until June 30, 2023. 
* Rationale for observation period 
A review of the first infusion cycles of AEs in adult subjects with relapsed or refractory CD30 
positive HL and sALCL in foreign phase 2 studies (SG035-0003 and SG035-0004 studies) 
showed that many AEs tended to occur by 16 cycles. In a special drug use surveillance in 
patients with relapsed or refractory CD30 positive HL and ALCL, 98.2% (660/672) of patients 
experienced adverse reactions by 336 days after the initiation of treatment. Based on the above, 
it was considered that the incidence of events that were included in the safety specification in 
this survey could be generally observed within 12 months from the start of administration. 
 
8.2 
REQUEST AND CONTRACT FOR MEDICAL INSTITUTIONS 
The person in charge of Takeda Pharmaceutical Co., Ltd. (hereinafter referred to as the person 
in charge of Takeda) will request this investigation on the premise that a written agreement 
with the participating medical organization will be concluded. 
(1) Request for cooperation in this study 
Using the Request for Cooperation in Special drug use surveillance, Outline of 
Implementation, Registration Form for Patients (Sample), and Questionnaire (Sample), the 
person in charge of Takeda explained the objectives, content, investigation methods, and drug 
information on proper use of the survey to the physician-in-charge, and obtained approval 
from the physician-in-charge for cooperation in the survey. 
(2) Contract for investigation 
The person in charge of Takeda makes a written contract with the medical institution 
immediately after the approval of the physician-in-charge of the investigation, and brings the 
"Patient Registration Form" to the physician-in-charge of the investigation. 
 
8.3 
PATIENT'S CONSENT 
Prior to enrolling patients, the physician-in-charge shall explain the content of the 
consent/information document to the patient (or legally acceptable representative) and obtain 
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the patient's (or legally acceptable representative) oral or written consent to provide 
information for the survey. 
When obtaining written informed consent, the patient (or legally acceptable representative) 
shall sign and date the informed consent form. The investigator shall retain the original of the 
signed consent form. 
The informed consent form states that the patient can discontinue participation in the survey 
without disadvantage of treatment, without explaining the details of the information provision, 
the handling of the patient's personal information and personal medical information in this 
survey, and the patient's reason at any time. 
Give the identification number to the patient from whom the consent was obtained. 
 
8.4 
HOW TO ENROLL PATIENTS 
This is carried out by "central registration system" by mail. 
The person * designated by the investigator or the investigator shall mail the "Patient 
Registration Form" to the central registration center basically 30 days after the starting day of 
administration of drug (the starting day of administration is defined as "day 0" and the day 
after the starting day of administration is defined as "day 1"). Patients who were started on or 
after the date of approval for the indication of CD30 positive PTCL in drug may be 
retrospectively enrolled even if the treatment was started prior to the conclusion of the contract. 
* The term "person designated by the investigator" is defined as a person who belongs to the medical institution 
concerned (including a person who has concluded a contract with the medical institution such as the dispatched 
CRC) and who, after being designated by the investigator in advance, performs the duties related to the 
investigation based on the instructions of the investigator. When a person designated by a physician in charge 
of the investigation performs duties such as patient registration, the physician who is responsible for the 
investigation (one person for each investigation site or clinical department at the time of the contract) shall 
prepare a record of the designation and date of designation (irrespective of the form), sign or subscribe and seal 
the record, and submit the record to the person in charge of Takeda. 
 
 
8.5 
PREPARATION AND SUBMISSION OF SURVEY FORMS 
Collect information using paper questionnaires. 
For all enrolled cases, the investigator or a person designated by the physician-in-charge shall 
promptly prepare a questionnaire after completion of the observation period for each case, sign 
or seal the questionnaire, and submit the questionnaire to Takeda Pharmaceutical Co., Ltd. 
If drug treatment is discontinued or dropped out during the observation period for any reason, 
the investigator or a person designated by the investigator shall promptly prepare a 
questionnaire and submit it to Takeda Pharmaceutical Co., Ltd. after completion of the 
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required observation period. However, for cases in which administration of drug is 
discontinued or dropped out due to the onset of adverse events, the investigator will continue 
observation after discontinuing administration until the adverse event recovers or resolves as 
much as possible, and the investigator or the person designated by the investigator will prepare 
a questionnaire and submit it to Takeda Pharmaceutical Co., Ltd. 
 
 
9.0 
DURATION OF THE PROJECT 
Survey period: from the date of approval for the indication of CD30 positive PTCL in 
ADCETRIS to September 30, 2023 
Patient registration period: NOTE) from the date of approval for the indication of CD30 positive 
PTCL in ADCETRIS to June 30, 2023 
Survey Completion date (Estimated completion date of Statistical Analysis): planed as 
Decmber 31, 2023 
 
NOTE) Patient enrollment will not be accepted after July 1, 2023 even if the administration 
of drug was started by June 30, 2023. 
If the enrolled subjects will reach the planned number of adult or pediatric subjects (80 
adult subjects and 6 pediatric subjects in the safety analysis set) before June 30, 2023, the 
enrollment reception for adult or pediatric subjects will be completed before the patient 
enrollment period. If the patient enrollment period is shortened, the investigation period 
will be changed according to the shortened period. 
 
10.0 
EXAMINATIONS AND OBSERVATIONS 
A person designated by the physician-in-charge of the survey or the physician-in-charge of the 
survey writes the following items in the patient registration sheet and the survey form. 
10.1 PATIENT ENROLLMENT 
1) Investigation items 
Date of commencement (planned) of administration of ADCETRIS, patient identification 
number, sex, age, inclusion criteria, exclusion criteria, and presence or absence of consent 
2) Time of investigation 
At the time of patient registration 
   
10.2 PATIENT CHARACTERISTICS 
1) Investigation items 
Diagnosis of PTCL or HL; diagnosis name; PTCL type; lesion site; clinical stage (Ann 
Arbor or Murphy classification); recurrent or refractory disease category; presence or 
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absence of B symptoms; ECOG Performance Status; treatment category; complications 
(presence or absence and detail); medical history (presence or absence and detail); 
smoking history, height, body weight; and presence or absence of pregnancy or lactation 
(females only) 
2) Time of investigation 
Initiation of drug treatment 
 
10.3 TREATMENT OF PTCL OR HL PRIOR TO INITIATION OF DRUG TREATMENT 
1) Investigation items 
Number of regimens, pharmacotherapy (presence/absence and details), presence/absence 
of radiotherapy, hematopoietic stem-cell transplantation (presence/absence and details), 
date of completion of treatment immediately before administration of ADCETRIS 
2) Time of investigation 
Initiation of drug treatment 
 
10.4 TREATMENT 
1) Investigation items 
ADCETRIS status, reason for discontinuation or termination of ADCETRIS, concomitant 
medication status (presence/absence, drug name, duration, and objective of 
administration), radiotherapy status (presence/absence and detail) 
2) Time of investigation 
Between the initiation of ADCETRIS treatment and Month 12 (until the time of 
discontinuation/dropout) 
 
10.5 BENEFICIAL AGAINST COLORECTAL 
1) Test item 
PTCL other than adult T-cell leukaemia/lymphoma (ATLL) or HL: Best Response will be 
determined by CR, CRu (if PET was not measured), PR, SD, or PD according to the 
results of CT and PET of the neck, chest, abdomen, and pelvis, and according to the 
antitumor response criteria. 
ATLL: Best Response is assessed by CR, PR, SD, PD, or NE according to response 
criteria. 
Childhood PTCL or HL: To determine Best Response according to the Japanese 
Childhood Leukemic Lymphoma Study Group (JPLSG) edition of Childhood PTCL or 
the Antitumor Efficacy Criteria for Childhood HL. 
 
2) Time of investigation 
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Between the initiation of ADCETRIS treatment and Month 12 (after 
discontinuation/dropout at that time) 
(However, until before the start of the next treatment) 
 
10.6 LAST DAY OF OBSERVATION 
1) Investigation items 
Last day of observation 
(the closest examination date to the date when the questionnaire was completed) 
2) Time of investigation 
12 months after commencement of administration (after discontinuation/dropout at that 
time) 
 
10.7 OTHER OBSERVATIONS 
1) Observation items 
Presence or absence of pregnancy during the observation period (only in women), 
withdrawal of consent (only in patients who withdrew consent) 
2) Time of investigation 
Between the initiation of ADCETRIS treatment and Month 12 (until the time of 
discontinuation/dropout) 
 
10.8 ADVERSE EVENTS 
Peripheral neuropathy, myelosuppression (neutropenia), pulmonary disorder, adverse events 
leading to discontinuation of ADCETRIS, and serious adverse events that fall under the Safety 
Specification will be collected regardless of the CTCAE Grade. All other events are subject to 
CTCAE Grade3 or higher. 
1) Investigation items 
AEs, names of adverse events, categories of adverse events (peripheral neuropathy), symptoms 
(peripheral neuropathy), onset date, CTCAE Grade*(worst-case and worst-case onset date), 
seriousness and serious reason, changes in drug dosage and administration (presence or absence and 
details), other actions for the event (presence or absence and details), date of outcome assessment, 
outcome, causal relationship with ADCETRIS **, and changes in laboratory values (neutrophil count, 
etc.) related to the adverse events included in the Safety Specification 
If the outcome is judged to be unresolved or unknown, follow-up will be conducted 
whenever possible. 
*Evaluate according to the “ National Cancer Institute Common Terminology Criteria for Adverse 
Events (NCI CTCAE v5. 0)”.   In addition, when the standard values of laboratory values peculiar 
to children are required at the time of Grade evaluation, refer to Vol. 112, No. 7, 1117-1132 of the 
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Journal of the Japanese Society of Pediatrics (2008). 
** If ADCETRIS is assessed to be not related, the rationale for assessment should be collected. 
 
2) Safety specification 
The following events will be regarded as safety specification, and at the time of 
occurrence, detailed information will be collected whenever possible. 
・ Peripheral neuropathy, myelosuppression (neutropenia), pulmonary disorder 
 
* Rationale for safety specification 
The special drug use surveillance (all-case survey) in adults with relapsed or refractory 
CD30 positive HL and ALCL patients was conducted with peripheral neuropathy, 
infections, neutropenia, infusion reaction, and pulmonary disorder as priority survey 
items. The incidence of adverse drug reactions etc. obtained in the all-case survey did not 
exceed the expected range based on the information up to the time of approval. However, 
the incidence of adverse drug reactions in peripheral neuropathy and neutropenia was 
high (44.26% and 34.51%, respectively). The incidence of pulmonary disorder was 0.6% 
in foreign clinical studies and 4.58% in all-case surveys, while these were not observed in 
Japanese clinical studies. Therefore, the incidence and seriousness of peripheral 
neuropathy, myelosuppression (neutropenia), and pulmonary disorder in Japanese patients 
including pediatric patients should be checked after the indication of CD30 positive PTCL 
has been approved. Therefore, these events were included in the safety specification. 
 
3) Time of investigation 
Between the initiation of ADCETRIS treatment and Month 12 (until the time of 
discontinuation/dropout) 
 
 
11.0 
ANALYSIS ITEMS AND METHODS 
11.1 ITEMS RELATED TO CASE COMPOSITION 
The number of patients enrolled, the number of patients collected in the questionnaire, the 
number of patients evaluable for safety and efficacy, the number of patients excluded from 
evaluation, and the reason for exclusion will be tabulated. 
 
11.2 PATIENT CHARACTERISTICS 
Patient characteristics such as sex, age, diagnosis, disease duration, lesion site, disease type, 
and clinical stage will be tabulated. 
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11.3 TREATMENT 
The status of administration of ADCETRIS, etc. will be tabulated. 
 
11.4 SAFETY ISSUES 
The following tabulation will be conducted for patients evaluated for safety. Adverse events 
will be read using MedDRA/J and summarised by preferred term (Preferred Term; PT) and 
system organ class (System Organ Class; SOC). 
11.4.1 Incidence of adverse events 
The frequency of adverse events that occurred during the run-in period will be tabulated by 
time of onset, severity (CTCAE Grade) seriousness, and causality to ADCETRIS. 
 
11.4.2 Factors that may affect safety 
The incidence of adverse drug reactions that occurred during the observation period will be 
tabulated by stratification of patient background factors (e.g., gender). 
 
11.5 ITEMS RELATED TO EFFICACY 
The following tabulation is performed on the efficacy evaluation population. 
11.5.1 Antitumor effects (Best Response) 
The antitumor effects (Best Response) at 12 months after the initiation of ADCETRIS 
treatment will be tabulated. 
 
11.5.2 Overall survival 
The time to death (regardless of cause of death) will be tabulated using the date of 
confirmation of survival as the "last observation day" in Section 10.6 and the date of death 
as the "outcome assessment" in the "Outcome" section in the "Adverse Events" section in 
Section 10.8. 
 
12.0 
REGISTRATION OF SURVEY INFORMATION 
Prior to the commencement of this survey, information from this survey will be registered on 
the following public websites. 
・ Clinical trial information, Japan Pharmaceutical Information Center: 
Japan Pharmaceutical Information Center-Clinical Trials Information 
・ National Institutes of Health registry: ClinicalTrials.gov 
 
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13.0 
ORGANIZATIONAL STRUCTURE 
13.1 MANAGEMENT REPRESENTATIVE 
Takeda Pharmaceutical Co., Ltd. 
 
 
13.2 MEDICAL ADVISOR 
 
 
 
     
 
                             (Unordered) 
 
14.0 
CONTRACT RESEARCH ORGANIZATION 
(1) 
 
 
Assignment:Registration center, data management operations, storage of records, medical 
writing, and support operations related to post-marketing surveys 
 
(2) 
 
 
Assignment: Statistical analysis 
 
(3) 
 
 
Assignment: Monitoring 
 
15.0 
ADDITIONAL ACTIONS THAT MAY BE TAKEN BASED ON THE RESULTS OF 
THE INVESTIGATION 
See Draft Risk Management Plan 2. Summary of Pharmacovigilance Plan 
 
16.0 
IMPLEMENTATION STATUS OF THE INVESTIGATION, TIME OF MILESTONE 
ASSESSMENT OR REPORTING 
See Draft Risk Management Plan 2. Summary of Pharmacovigilance Plan 
 
17.0 
OTHER REQUIRED ITEMS. 
17.1 PROTOCOL AMENDMENT 
During the study period, the status of progress, the occurrence of unexpected adverse 
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reactions/serious adverse reactions based on the precautions, the presence or absence of an 
increase in the incidence of specific adverse reactions, and the appropriateness of investigation 
items will be ascertained. If necessary, this protocol will be reviewed and revised. If approval 
for partial changes in dosage and administration or indications is received during the study 
period, the necessity of revision of this protocol should be considered as necessary, and the 
protocol should be revised as necessary. 
17.2 MEASURES TO BE TAKEN IN THE EVENT THAT PROBLEMS OR QUESTIONS ARE IDENTIFIED 
If any problems with safety or efficacy are found, data should be carefully reviewed and 
actions taken. 
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Document History 
 
Version 
Date 
Comments 
original version 
2020/1/29 
New document 
2nd version 
2021/1/15 
To add “14.0 Contract Research Organization” and other minor 
changes 
3rd version 
2021/3/31 
To extend the patient registration period and survey period 
4th version 
2022/4/4 
To define the end of the observation period for patients who 
started ADCETRIS after July 1, 2022, and to extend the overall 
registration period 
5th version 
2022/5/11 
To add minor changes in “13.0 Organizational Structure” 
6th version 
2023/4/6 
To add minor changes in “15.0 Contract Research Organization” 
7th version 
2023/9/12 
To add the survey completion date (completion date of statistical 
analysis) in “9.0 Duration of the Project” 
 
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