Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
Conditions: Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, Erythrodermic Psoriasis
Sponsor: Pfizer

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(Appendix)
Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer”
General investigation
(Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or 
Erythrodermic Psoriasis)
NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Pfizer Japan Inc.
This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, 
by accepting or reviewing this document, you agree to hold this information in confidence and not copy or 
disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In the event of 
any actual or suspected breach of this obligation, Pfizer must be promptly notified.
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STUDY INFORMATION
Title
Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer”
Drug Use Investigation (Psoriasis Vulgaris, Psoriasis 
Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
Protocol number
B5371009
Protocol version 
identifier
Version 8
Date
18 October 2022
Active substance
Infliximab (genetical recombination) [infliximab biosimilar 3]
Medicinal product
Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer”
Research question 
and objectives
To collect information on the safety and effectiveness of 
Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer” 
against psoriasis vulgaris, psoriasis arthropathica, pustular 
psoriasis, or erythrodermic psoriasis under actual status of use.
Author
PMS Planning & Operations Group 2, PMS Affairs
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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................3
2. LIST OF ABBREVIATIONS................................................................................................7
3. RESPONSIBLE PARTIES....................................................................................................8
4. AMENDMENTS AND UPDATES.......................................................................................9
5. MILESTONES.....................................................................................................................11
6. RATIONALE AND BACKGROUND................................................................................11
7. RESEARCH QUESTION AND OBJECTIVES .................................................................12
7.1. Safety specifications................................................................................................12
8. RESEARCH METHODS ....................................................................................................12
8.1. Study design ............................................................................................................12
8.2. Setting......................................................................................................................12
8.2.1. Registration criteria ....................................................................................13
8.2.2. Study sites...................................................................................................13
8.2.3. Planned study period...................................................................................13
8.2.4. Study procedures ........................................................................................13
8.2.4.1. Study method.............................................................................13
8.2.5. Observation period......................................................................................13
8.3. Variables..................................................................................................................14
8.3.1. Patient characteristics .................................................................................15
8.3.2. Prior and concomitant medications ............................................................16
8.3.2.1. Drugs used to treat psoriasis......................................................16
8.3.2.2. Drugs used to prevent infection (including vaccines)...............16
8.3.2.3. Drugs used to prevent infusion reaction....................................16
8.3.2.4. Drugs used to treat adverse events ............................................17
8.3.3. Non-drug therapies .....................................................................................17
8.3.3.1. Non-drug therapies to treat psoriasis.........................................17
8.3.3.2. Non-drug therapies to treat adverse events ...............................17
8.3.4. Targeted drug use record ............................................................................17
8.3.5. Tests............................................................................................................18
8.3.6. Clinical evaluation of effectiveness............................................................18
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8.3.6.1. Observation items......................................................................18
8.3.6.2. Effectiveness evaluation scale for each disease ........................18
8.3.7. Presence or absence of pregnancy (women only).......................................19
8.3.8. Confirmation of the day of study completion and administration status....19
8.3.9. Adverse events............................................................................................19
8.4. Adverse events of note ............................................................................................20
8.5. Data sources ............................................................................................................21
8.6. Study size ................................................................................................................21
8.6.1. Planned sample size....................................................................................21
8.6.2. Rationale for sample size............................................................................21
8.7. Data management....................................................................................................21
8.7.1. Case report forms (CRFs)/ Electronic data record .....................................21
8.7.2. Record retention..........................................................................................22
8.7.3. Data collection method (EDC) ...................................................................22
8.7.4. Patient registration (EDC) ..........................................................................22
8.7.5. Points to consider for completion, revision, and submission of case 
report form (EDC)............................................................................................22
8.7.5.1. Data entry ..................................................................................22
8.7.5.2. Data revision .............................................................................22
8.7.5.3. Submission ................................................................................22
8.7.6. Data collection method (paper CRFs) ........................................................23
8.7.7. Patient registration (paper CRFs) ...............................................................23
8.7.8. Points to consider for completion, revision, and submission of case 
report form (paper CRFs).................................................................................23
8.7.8.1. Data entry ..................................................................................23
8.7.8.2. Data revision .............................................................................23
8.7.8.3. Submission ................................................................................24
8.7.9. All cases survey registration.......................................................................24
8.8. Data analysis ...........................................................................................................24
8.8.1. Definition of analysis set ............................................................................24
8.8.2. Method of analysis......................................................................................24
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8.8.2.1. Analysis for safety evaluation...................................................24
8.8.2.2. Analysis for effectiveness evaluation........................................24
8.9. Quality control.........................................................................................................24
8.10. Limitations of the research methods .....................................................................25
8.11. Other aspects .........................................................................................................25
9. PROTECTION OF HUMAN SUBJECTS ..........................................................................25
9.1. Patient information..................................................................................................25
9.2. Patient consent.........................................................................................................26
9.3. Institutional review board (IRB)/Independent ethics committee (IEC)..................26
9.4. Ethical conduct of the study....................................................................................27
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................27
10.1. Requirements.........................................................................................................27
10.2. Reporting period....................................................................................................28
10.3. Causality assessment.............................................................................................28
10.4. Definitions of safety events...................................................................................29
10.4.1. Adverse events..........................................................................................29
10.4.2. Serious adverse events..............................................................................30
10.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours .........31
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........34
12. NAME, AND ADDRESS OF CONTRACTOR AS WELL AS SCOPE OF WORK
CONTRACTED..................................................................................................................35
13. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON THE 
STUDY RESULTS AND CRITERIA FOR DETERMINATION OF THE INITIATION35
14. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
EVALUATION OF STUDY IMPLEMENTATION STATUS AND RESULTS AND 
REPORTING TO THE PMDA...........................................................................................36
15. OTHER NECESSARY MATTERS ..................................................................................36
15.1. Amendment of the Study Protocol........................................................................36
15.2. Actions to be taken for any problem or issue........................................................36
16. CONTACT INFORMATION............................................................................................36
16.1. Contact information for inquiries about the study ................................................36
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16.2. Contact information for inquiries about the EDC system.....................................36
17. REFERENCES ..................................................................................................................37
18. LIST OF TABLES.............................................................................................................37
19. LIST OF FIGURES ...........................................................................................................37
ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................37
ANNEX 2. ADDITIONAL INFORMATION.........................................................................37
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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
BSA
Body surface area involvement
CRP
C-reactive protein
CT
Computed Tomography
DAS
Disease Activity Score
EDC
Electronic Data Capture
NA
Not applicable
PASI
Psoriasis Area and Severity Index
VAS
Visual Analogue Scale
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3. RESPONSIBLE PARTIES
The Japan Good Post-Marketing Study Practice officer
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4. AMENDMENTS AND UPDATES
Amendment 
number
Date
Protocol 
section(s) 
changed 
Summary of 
amendment(s)
Reason
Amended 7
October 
18, 2022

Study 
information

Section 16.1

Change of 
department name of 
author

Change of
department name

Due to change of 
organization

Section 5

Section 8.10

Section 9.4

Section 12

Addition of items

Change of terms

Adjustment of 
description

Adjustment of 
description

Because the standard 
template was revised

Section 6

Change of 
ministerial 
ordinances

Due to partial revision 
of ministerial 
ordinances

Section 8.3.9 
and 10

Change of terms,
etc.

Due to change of 
internal form

Previous 
section 12

Deletion, and all 
subsequent section 
numbers have been 
revised

Amendment 
associated with the 
notification “Planning 
and publication of 
Risk Management 
Plan” dated 18 March 
2022

Section 12

Addition of work 
contracted

Due to expansion of 
scope of work 
contracted

Section 16.2

Change of contact
information

Due to change of 
contact information
Amended 6
October 
22, 2021

Section 
numbers

Section 8.7.9

The table of contents 
has been 
renumbered to 1, 
and all section 
numbers have been 
revised

Editing the 
descriptions of the 
confirmation method 
for all patients 
registration

Because the standard 
template was revised

To specify the 
confirmation method
Amended 5
September 
17, 2021

Study 
information

Change of author

Adjustment of 
description

Due to change of 
author
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Amendment 
number
Date
Protocol 
section(s) 
changed 
Summary of 
amendment(s)
Reason

Sections 1, 
7.8.2.2 and 
16.2

Section 4 

Section 7.2.3

General

Change of End of 
data collection and 
Final study report

Change of 
Registration period 
and Investigation 
study period

Editing of 
descriptions 
associated with 
revision of the 
standard template

Adjustment of 
description

Due to extension of 
the Registration period 
and Investigation 
study period

Due to extension of 
the Registration period 
and Investigation 
study period

Because the standard 
template was revised
Amended 4
May 30, 
2019

Section 9

Section 16.2

General

Change of terms

Change of e-mail 
address for inquiries

Standardization of 
expressions

Due to change of 
internal form

Due to change of e-
mail address

Adjustment of 
description
Amended 3
February 
15, 2019

Sections 4

Change in 
investigation 
schedule

The date of 
preparation of the final 
report was changed.
Amended 2
January 10
，2019

Sections 4 
and 7.2.3

Sections 8.1 
and 8.2

General

Change in 
investigation
schedule

Description of 
obtaining informed 
consent from 
patients to be 
surveyed regarding 
disclosure, 
publication, etc. of 
survey results

Editing of 
descriptions 
associated with 
revision of the 
standard template

Due to revision of the 
protocol

Because it was 
decided to obtain 
consent from the 
patients to be surveyed 
regarding the use of 
investigation results 
for other purposes.

Because the standard 
template was revised.
Amended 1
December 
1, 2018

Section 13

Section 17.1

Contractor was 
added

Change in the name 
of the contact
Establishment of  Pfizer 
R&D Japan
Final
July 31, 
2018
NA
NA
NA
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5. MILESTONES
Milestone
Planned date
Start of investigation period
February 2019
Start of data collection (registration date for the first
registered patient)
21 October 2019
End of investigation period
August 2024
End of data collection (date of database release)
12 March 2025
Final study report
September 2025
6. RATIONALE AND BACKGROUND
Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer” (generic name, infliximab 
[genetical recombination] [infliximab biosimilar 3]) (hereinafter, this drug) is a drug developed 
by Pfizer as a biosimilar of the original biopharmaceutical Remicade (the generic name and 
brand name of the product approved in Japan are infliximab [genetical recombination] and 
Remicadefor Intravenous Drip Infusion 100, respectively).
In Infliximab BS for Intravenous Drip Infusion 100 mg “Pfizer” Drug Use Investigation
(Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis) 
(hereinafter, this study), information of the safety and effectiveness of this drug against psoriasis 
vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status 
of use will be collected.
This study shall be conducted in strict compliance with the following ministerial ordinances and 
notifications:

“MHLW Ordinance on the Standard for Post-Marketing Studies and Clinical Trials of 
Medical Products” (MHLW Ordinance No. 171, dated December 20, 2004)

“Enforcement of the MHLW Ordinance on the Standard for Post-marketing Studies and 
Clinical Trials of Medical Products” (PFSB Notification No. 1220008, dated December 
20, 2004)

“MHLW Ordinance on the Standard for Post-marketing Safety Control of Medical 
Products, Quasi-medical Products, Cosmetics, Medical Devices and Regenerative 
Medical Products” (MHLW Ordinance No. 135, dated September 22, 2004)

“Enforcement of the MHLW Ordinance on the Standard for Post-marketing Safety 
Control of Medical Products, Quasi-medical Products, Cosmetics, and Medical Devices, 
Regenerative Medical Products” (PFSB Notification No. 0812-4, dated August 12, 2014)
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
“MHLW Ordinance on the Partially Amend the MHLW Ordinance on the Standard for 
Post-marketing Studies and Clinical Trials of Medical Products” (MHLW Ordinance No. 
116, dated October 26, 2017)

“Announcement of the MHLW Ordinance on the Partially Amend the MHLW Ordinance 
on the Standard for Post-marketing Studies and Clinical Trials of Medical Products 
(related to the MHLW Ordinance on the Standard for Post-marketing Studies and Clinical 
Trials of Medical Products” (PSEHB Notification No. 1026-1, dated October 26, 2017)
7. RESEARCH QUESTION AND OBJECTIVES
To collect information on the safety and effectiveness of this drug against psoriasis vulgaris, 
psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.
7.1. Safety specifications
[Important Identified Risks]

Delayed-type hypersensitivity

Lupus-like syndrome associated with seroconversion of anti-dsDNA antibody

Demyelinating disease

Hepatic impairment

Serious infusion reaction

Rhabdomyolysis

Reactivation of hepatitis B

Antibody production
[Important Potential Risks]

Infection due to inoculation of live vaccines in children
8. RESEARCH METHODS 
8.1. Study design
This study is a multi-center cohort study of patients with psoriasis vulgaris, psoriasis 
arthropathica, pustular psoriasis, or erythrodermic psoriasis receiving this drug. The investigators 
complete the case report form (CRF) based on the medical record containing data obtained in 
daily medical practice.
8.2. Setting
Patients meeting the registration conditions will be included in this study.
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8.2.1. Registration criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1.
Patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or
erythrodermic psoriasis who started treatment with this drug
2.
Patients who received this drug for the first time at the medical institution after the day 
of launch of this drug.
See the latest package insert in administering this drug.
8.2.2. Study sites
Conduct the study at 50 to 100 sites including the Department of Dermatology, Department of 
Orthopedic Surgery, etc.
8.2.3. Planned study period
The planned period covered by this investigation is as follows.
Investigation study: February 2019 to August 2024 (start of registration to completion of 
observation of the last registered patient)
Registration period: February 2019 to January 2024
8.2.4. Study procedures 
8.2.4.1. Study method
This study will be conducted with all-case investigation system in patients with psoriasis 
vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis.
This study will be conducted in patients who used this drug after the day of approval of dosage 
and administration for psoriasis at contracted medical institutions. Patients who used this drug 
before conclusion of the contract with the medical institution will also be included in this study 
(retrospective patients will be included).
8.2.5. Observation period
The observation period is 30 weeks* from the day of initial dose of this drug (Day 1). 
Information up to the day of visit immediately after 8 weeks have elapsed since the last dose 
during the observation period (day of study completion) will be collected in this study.
*: The period of 30 weeks is defined as up to Day 217 in consideration for allowance in visit days 
that occur in daily medical practice.
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8.3. Variables
This study will be conducted in accordance with the observation schedule in Table 1.
Table 1.
Variables and Schedule of observation
Timing
Variables
Registration 
form
CRF
At registration
At 
commencement 
of treatment
From 
commencement 
of treatment to 
day of study 
completion
Patient 
demographics
Identification number
●
Gender
●
●
Month of birth (or age at commencement 
of treatment with this drug)
●
●
Date of commencement of treatment with 
this drug
●
Check of registration conditions, target 
disease
●
Height
●
Weight
●
Target disease, duration of illness
●
Presence or absence and results of 
tuberculosis screening test, and record of 
administration of antituberculosis drugs
●
Presence or absence and results of hepatitis 
B virus test and hepatitis C virus test
●
Smoking history
●
Family history of malignant tumors 
(including lymphoma)
●
Medical history (past history and 
complications) (including the presence or 
absence of allergic history and hepatic 
impairment)
●
Presence or absence and duration of past 
use of infliximab preparations
●
Prior and concomitant medications
●
●
Non-drug therapies
●
●
Record of administration of this drug
●
●*
Tests
●
●
Effectiveness evaluation
Observation items: Skin findings and area of foci, and 
percentage of eruption to body surface area
●
●
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Effectiveness evaluation (psoriasis arthropathica only)
Observation items: Number of tender joints, number of 
swollen joints, patient’s assessment of overall activity 
(patient VAS), and C-reactive protein (CRP)
●
●
Effectiveness evaluation (pustular psoriasis only)
Observation item: Global improvement
●
Presence or absence of pregnancy (women only)
●
●
Confirmation of the day of study completion and 
administration status
●
Adverse events
●
●
*: Information on the use of this drug from the day of initial dose to the last dose during the observation period (30 weeks) will 
be collected.
8.3.1. Patient characteristics 
Information at commencement of treatment with this drug will be entered in the 
registration form.
1.
Identification number
2.
Gender
3.
Month of birth (or age at commencement of treatment with this drug)
4.
Date of commencement of treatment with this drug
5.
Check of registration conditions, target disease (psoriasis vulgaris, psoriasis 
arthropathica, pustular psoriasis, or erythrodermic psoriasis)
The following information at commencement of treatment with this drug will be entered in 
the CRF.
1.
Height (cm)
2.
Weight (kg)
3.
Gender
4.
Month of birth (or age at commencement of treatment with this drug)
5.
Target disease (psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or 
erythrodermic psoriasis), duration of illness (date of diagnosis)
6.
Presence or absence and results of tuberculosis screening test (diagnostic 
imaging/tuberculin reaction test/interferon γ release test [QuantiFeron Test, T spot test, 
etc.]) and record of administration of antituberculosis drugs
7.
Presence or absence and results of hepatitis B virus test and hepatitis C virus test (HBs 
antigen, HBs antibody, HBc antibody, and HCV antibody)
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8.
Smoking history
9.
Family history of malignant tumors (including lymphoma)
10. Medical history (past history and complications) (including the presence or absence of 
allergic history and hepatic impairment)
11. Presence or absence and duration of past use of infliximab preparations
8.3.2. Prior and concomitant medications
8.3.2.1. Drugs used to treat psoriasis
The following information will be entered for drugs used to treat psoriasis immediately before 
the initial dose of this drug and concomitant medications used to treat psoriasis between the day 
of initial dose of this drug and the day of study completion.
1.
Name of drug (product name)
2.
Route of administration
3.
Period of administration
4.
Reason for discontinuation (inadequate effectiveness/adverse event/others)
8.3.2.2. Drugs used to prevent infection (including vaccines)
The following information will be entered for drugs used to prevent infection (including 
vaccines) between 6 months before the day of initial dose of this drug and the day of study 
completion.
1.
Name of drug (product name)
2.
Route of administration
3.
Period of administration
4.
Total daily dose and frequency of administration
5.
Target of prophylactic administration
8.3.2.3. Drugs used to prevent infusion reaction
The following information will be entered for drugs used to prevent infusion reaction from 
before the initial dose of this drug to the day of study completion.
1.
Name of drug (product name)
2.
Route of administration
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3.
Period of administration
4.
Total daily dose and frequency of administration
8.3.2.4. Drugs used to treat adverse events
The following information will be entered for drugs used to treat adverse events between the day 
of initial dose of this drug and the day of study completion.
1.
Name of drug (product name)
2.
Route of administration
3.
Period of administration
8.3.3. Non-drug therapies
8.3.3.1. Non-drug therapies to treat psoriasis
The following information will be entered for non-drug therapies performed to treat psoriasis 
between 6 months before the day of initial dose of this drug and the day of study completion.
1.
Name of therapy (name of procedure for surgery, etc.)
2.
Period of implementation
8.3.3.2. Non-drug therapies to treat adverse events
The following information will be entered for non-drug therapies performed to treat adverse 
events between the day of initial dose of this drug and the day of study completion.
1.
Name of therapy (name of procedure for surgery, etc.)
2.
Period of implementation
8.3.4. Targeted drug use record
The following information will be entered for the status of use of this drug between the day of 
initial dose of this drug and the last dose during the observation period (30 weeks).
1.
Dose
2.
Weight
3.
Date of administration
4.
Reason for change
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8.3.5. Tests
The results of tests performed between 3 months before the day of initial dose of this drug and 
the day of study completion will be entered.
1.
Presence or absence of chest X-ray or chest CT, and presence or absence of abnormal 
findings
2.
Laboratory tests: KL-6 and -D-glucan (measured ranges and site reference ranges)
8.3.6. Clinical evaluation of effectiveness
Effectiveness will be evaluated based on the results of the following observation items.
8.3.6.1. Observation items
The results of the following items from before the initial dose of this drug (including the day of 
initial dose) to the day of study completion will be entered.
8.3.6.1.1. Observation items for psoriasis vulgaris, pustular psoriasis, or erythrodermic 
psoriasis
1.
Skin findings (erythema, infiltration/thickening, and scale) and area of foci
2.
Percentage of eruption to body surface area
8.3.6.1.2. Observation items for psoriasis arthropathica
1.
Skin findings (erythema, infiltration/thickening, and scale) and area of foci
2.
Percentage of eruption to body surface area
3.
Number of tender joints (assessment of 28 joints)
4.
Number of swollen joints (assessment of 28 joints)
5.
Patient’s assessment of overall activity (patient VAS)
6.
C-reactive protein (CRP)
8.3.6.2. Effectiveness evaluation scale for each disease
8.3.6.2.1. Effectiveness evaluation scale for psoriasis vulgaris or erythrodermic psoriasis
The following will be calculated based on information collected for observation items to evaluate 
effectiveness.

Psoriasis area and severity index (PASI) score

BSA (Body surface area involvement)
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8.3.6.2.2. Effectiveness evaluation scale for psoriasis arthropathica
For psoriasis arthropathica, the following will be calculated based on information collected for 
observation items in addition to PASI score and BSA to evaluate disease activity.

Disease Activity Score (DAS) 28
8.3.6.2.3. Effectiveness evaluation scale for pustular psoriasis
For pustular psoriasis, the following assessment by the investigator will be evaluated in addition 
to PASI score and BSA.

Global improvement
8.3.7. Presence or absence of pregnancy (women only)
The presence or absence of pregnancy between the day of initial dose of this drug and the day of 
study completion will be entered.
8.3.8. Confirmation of the day of study completion and administration status
The following information will be entered as to whether treatment with this drug is ongoing on 
the day of study completion.
1.
Date of study completion
2.
Whether treatment is ongoing
3.
Reason for discontinuation (completion) (choose from the following)
a.
Remitted (symptom improved)
b. Inadequate clinical effect
c.
Adverse event (enter necessary information in the adverse event column)
d. No revisit
e.
Others (enter reasons for discontinuation)
8.3.9. Adverse events
An Adverse Event (AE) is any untoward medical occurrence in a patient administered a 
medicinal product.
Occurrence of adverse events from the start date of administration of this drug to the end date of 
observation period should be confirmed and the following information should be recorded. 
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Also, further investigation should be separately conducted, if deemed necessary by Sponsor for 
patients who experienced a serious adverse reaction, an unexpected adverse reaction or other 
adverse reactions not listed in the package insert. 
1.
Presence/absence of adverse events
2.
Name of adverse event
3.
Category of adverse event (whether it falls under infusion reaction and timing of onset)
4.
Date of occurrence
5.
Intervention
6.
Seriousness
7.
Outcome
8.
Date of outcome
9.
Causal relationship 
If the adverse event is associated with abnormal laboratory values, i.e., clinical laboratory tests, 
the following information should also be recorded.
10. Presence or absence of tests related to adverse events
11. Date of test
12. Name of test
13. Site reference value
14. Unit
15. Results 
8.4. Adverse events of note
Adverse events of note in this study are shown below.
Serious infection (pneumonia, Pneumocystis pneumonia, sepsis, opportunistic infection, etc.), 
tuberculosis, delayed-type hypersensitivity, serious blood disorder, lupus-like syndrome 
associated with seroconversion of anti-dsDNA antibody, demyelinating disease, hepatic 
impairment, serious infusion reaction, interstitial pneumonia, rhabdomyolysis, reactivation of 
hepatitis B, antibody production, malignant tumor, and infection due to inoculation of live 
vaccines in children
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8.5. Data sources
In this study, the investigators transcribe the necessary information from the medical record 
under daily medical practice in accordance with the protocol.
8.6. Study size
8.6.1. Planned sample size
Target sample size is to be 100 subjects for safety analysis (At least 50 patients with psoriasis 
vulgaris and at least 5 patients with psoriasis arthropathica. Patients with pustular psoriasis and 
erythrodermic psoriasis will be collected as much as possible.)
If the target sample size is not reached at completion of the registration period, Sponsor will 
discuss measures with PMDA.
8.6.2. Rationale for sample size
The target sample size was set at 100 taking the feasibility of the study into consideration.
The data collected from 100 subjects to whom this drug is administered should enable to detect 
and verify, with a probability of 95%, at least 1 subject in whom each adverse event with an 
incidence of 3% or more occurs.
8.7. Data management 
8.7.1. Case report forms (CRFs)/ Electronic data record
As used in this protocol, the term CRF should be understood to refer to, either a paper form or an 
electronic data record or both, depending on the data collection method used in this study.
A CRF is required and should be completed for each included patient. The completed original 
CRFs are the sole property of Pfizer and should not be made available in any form to third 
parties, except for authorized representatives of Pfizer or appropriate regulatory authorities, 
without written permission from Pfizer. The investigator shall ensure that the CRFs are securely 
stored at the study site in encrypted electronic and/or paper form and will be password protected 
or secured in a locked room to prevent access by unauthorized third parties.
The investigator has ultimate responsibility for the collection and reporting of all clinical, safety, 
and laboratory data entered on the CRFs and any other data collection forms (source documents) 
and ensuring that they are accurate, authentic/original, attributable, complete, consistent, legible, 
timely (contemporaneous), enduring, and available when required. The CRFs must be signed by 
the investigator or by an authorized staff member to attest that the data contained on the CRFs
are true. Any corrections to entries made in the CRFs or source documents must be dated, 
initialed (or stamped with correction seal), and explained (if necessary) and should not obscure 
the original entry.
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The source documents are the hospital or the physician's chart. In these cases, data collected on 
the CRFs must match those charts.
8.7.2. Record retention
The records related to this study should be retained at the study site until the End of Study Letter 
by Pfizer is received or during the period defined by the study site, whichever is longer.
8.7.3. Data collection method (EDC)
The data for this study will be collected and confirmed by using the electronic system on the 
internet (Electronic Data Capture, EDC).
8.7.4. Patient registration (EDC)
After conclusion of the contract, target patients will be promptly registered. If an unregistered 
patient is found during the registration period, the patient will be promptly registered. All 
patients confirmed to have received this drug will be registered because this study will be 
conducted using all-case investigation system.
The investigator will enter registration items on the patient registration screen of EDC and save 
the data. Patient registration will be performed immediately after the first administration with 
this drug.
If there is something to be confirmed found in the registration form, confirmation will be 
requested with the investigator. Registration will be fixed after the confirmation.
8.7.5. Points to consider for completion, revision, and submission of case report form 
(EDC)
8.7.5.1. Data entry
The investigator shall, upon confirming the study items, input the data in this system based on 
medical charts, and save the data.
8.7.5.2. Data revision 
Upon receiving Sponsor's inquiry on the contents of the CRF (query forms), the investigator will 
again confirm the contents of medical records, and as required, correct relevant sections and save 
the data.
8.7.5.3. Submission
After data entry and revision are completed, CRFs should be signed electrically by the 
investigator following confirmation of entry and follow-up survey.
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8.7.6. Data collection method (paper CRFs)
In this study, the data will be collected and confirmed by using paper CRFs, only when the EDC 
is not available at the study sites.
8.7.7. Patient registration (paper CRFs)
After conclusion of the contract, target patients will be promptly registered. If an unregistered 
patient is found during the registration period, the patient will be promptly registered. All 
patients confirmed to have received this drug will be registered because this study will be 
conducted using all-case investigation system.
The investigator will complete the “registration form” provided by Sponsor for patients who 
received this drug and fax it to the toll-free number specified in the registration form.
【Patient Registration Center】
FAX：0120‐508‐123（Available 24 Hours）
Business hours：9:00～17:15*（except for Saturdays, Sundays, National 
Holidays, and New Year Holidays）
*：FAX transmission after 15:15 will be responded during the following 
business day.
1.
After the patient was registered, “the announcement of the patient registration” will be sent 
by FAX. Investigator will save the announcement in the site.
2.
If there is something to be confirmed found in the registration form, confirmation will be 
requested with the investigator. In the case of confirmation, “request form of confirmation” 
and “registration form (copy)” will be sent from the Registration Center to the investigator 
by FAX.
8.7.8. Points to consider for completion, revision, and submission of case report form 
(paper CRFs)
8.7.8.1. Data entry
The investigator shall, upon confirming the study items, complete the CRF based on medical 
charts and other medical records such as relevant test results, using an ineffaceable ink such as 
ballpoint pen.
8.7.8.2. Data revision 
Upon receiving Sponsor's inquiry on the contents of the CRF (query forms), the investigator will 
again confirm the contents of medical records described earlier, and as required, correct relevant 
sections and resubmit the form. 
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8.7.8.3. Submission
CRFs should be submitted promptly upon completion in accordance with the procedures set out 
by Sponsor.
8.7.9. All cases survey registration  
1.
Periodically, investigator will confirm whether all patients registered are recorded on “the 
list of patients registered in this study” or not, provide signature (or putting down the 
investigator’s name and putting investigator’s seal on), and submit the list to the site staff. 
However, if the medical institution has established restrictions on visits, etc., an alternative 
method such as e-mail should be used.
2.
If the unregistered patients were found, investigator will register the patient at once.
8.8. Data analysis 
8.8.1. Definition of analysis set
The safety analysis set (SAS) will be a full analysis set (FAS) that is as closer as possible to all 
patients who received this drug. The effectiveness analysis set will be a set of patients for whom 
the effectiveness evaluation is considered possible among the safety analysis set according to the 
separately prescribed Statistical Analysis Plan (SAP).
8.8.2. Method of analysis
8.8.2.1. Analysis for safety evaluation
The onset of major adverse reactions and incidence of adverse reactions (percentage of patients 
with adverse events for which the causal relationship with this drug cannot be ruled out) in the 
SAS will be analyzed. In addition, patient demographics and incidence will be tabulated for 
infusion reaction, hypersensitivity, and hepatic impairment in the SAS, and these events will be 
evaluated in terms of seriousness and whether treatment was required.
8.8.2.2. Analysis for effectiveness evaluation
Values before and after administration of this drug will be summarized for effectiveness 
endpoints based on PASI score, BSA, and DAS28.
Detailed methodology for summary and statistical analyses of data collected in this study will be 
documented in a Statistical Analysis Plan (SAP), which will be dated, filed and maintained by 
the sponsor. The SAP may modify the plans outlined in the protocol; any major modifications of 
primary endpoint definitions or their analyses would be reflected in a protocol amendment.
8.9. Quality control
Prior to conducting the study, the site staff will explain to the investigator about the contents of 
the protocol, etc. and ask the investigator for completion of a case report form based on medical 
charts.
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8.10. Limitations of the research methods
There may be potential limitations in this study:

Since no control group is included in the study, there is a limitation in determining whether 
or not a risk of developing adverse events and adverse reactions increases with
administration of this drug.

Due consideration may not be given to confounding factors due to insufficient background 
information collected. 

Since this study collects the information described in medical charts, specified data may not 
be collected or may be missing.
8.11. Other aspects
Not applicable
9. PROTECTION OF HUMAN SUBJECTS
9.1. Patient information
All parties will comply with all applicable laws, including laws regarding the implementation of 
organizational and technical measures to ensure protection of patient personal data. Such 
measures will include omitting patient names or other directly identifiable data in any reports, 
publications, or other disclosures, except where required by applicable laws. 
The personal data will be stored at the study site in [encrypted electronic and/or paper] form and 
will be [password protected or secured in a locked room] to ensure that only authorized study 
staff have access. The study site will implement appropriate technical and organizational 
measures to ensure that the personal data can be recovered in the event of disaster. In the event 
of a potential personal data breach, the study site shall be responsible for determining whether a 
personal data breach has in fact occurred and, if so, providing breach notifications as required by 
law.
To protect the rights and freedoms of natural persons with regard to the processing of personal 
data, when study data are compiled for transfer to Pfizer and other authorized parties, patient  
names will be removed and will be replaced by a single, specific, numerical code, based on a 
numbering system defined by Pfizer. All other identifiable data transferred to Pfizer or other 
authorized parties will be identified by this single, patient-specific code. The investigator site 
will maintain a confidential list of patients who participated in the study, linking each patient’s 
numerical code to his or her actual identity. In case of data transfer, Pfizer will maintain high 
standards of confidentiality and protection of patients’ personal data consistent with the clinical 
study agreement and applicable privacy laws.
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9.2. Patient consent
As this study does not involve data subject to privacy laws according to applicable legal 
requirements, or it is an information provision based on the law (even though that involve data 
subject to privacy laws according to applicable legal requirements), obtaining informed consent 
from patients by Pfizer is not required with regard to the personal information provision from the 
study site to Pfizer. Also, because the report of information or results collected in this study to 
the local regulatory authority or healthcare providers by Pfizer as needed is an information 
provision based on the law, obtaining informed consent from patients by Pfizer is not required.
In this study, Pfizer will collect information that cannot identify specific patients from the 
institutions. The results of this study, which are prepared not to identify specific patients, may be 
reported to Pfizer Inc., which is the corporate parent of the sponsor of this study, or group 
companies, or regulatory authorities in other countries, as needed, or published it as a 
presentation at academic conferences or manuscript for the purpose of providing proper use 
information for this drug. If these information falls under personal information of the Personal 
Information Protection Act, these actions may not be based on the laws or regulations, and 
therefore, may correspond to provision to the third party and using the information for purposes 
other than business that require consent from the patient. Therefore, the study institutions will 
obtain written or verbal consent from the patients to be included in this study so that Pfizer can 
use the results of this study to report to Pfizer Inc., group companies or regulatory authorities in 
other countries, or to present it at academic conferences or publish manuscript, etc. Whether 
consent is obtained from patients or not is described in the CRF. The original of the written 
informed consent form should be retained by the study investigator. 
In general, the investigator must obtain consent from a patient personally. However, if the 
investigator determines that a patient’s decisional capacity is so limited that he or she cannot 
reasonably be consulted or he or she is a minor, consent is obtained from legally acceptable 
representative or parent(s). In this case, every effort should be made to obtain the patient’s assent 
as far as possible after obtaining consent from legally acceptable representative or parent(s) if a 
minor. If the study patient does not provide his or her own consent, the source documents must 
record the relationship of the person signing the consent and the patient (e.g., parent(s), spouse). 
If a minor registered in the study reaches adulthood during the study, the consent will be 
reacquired as far as possible from the patient at the time of adulthood according to Japanese law. 
At the time of obtaining informed consent, the investigator must use informed consent form and 
other materials and ensure that each study patient, or his or her legally acceptable representative, 
or parent(s) if a minor, is fully informed about the information provided to Pfizer and the 
objectives of use and possible risks associated with consent.
9.3. Institutional review board (IRB)/Independent ethics committee (IEC)
In this study, review by the Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC) is not required.
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9.4. Ethical conduct of the study
This study will be conducted in compliance with the MHLW Ordinance in the section 6. 
RATIONALE AND BACKGROUND. Also, the study will be conducted in accordance with 
legal and regulatory requirements, as well as with scientific purpose, value and rigor.
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS
10.1. Requirements
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the non-interventional study (NIS) adverse event monitoring (AEM) 
Report Form to Pfizer Safety. These requirements are delineated for three types of events: (1) 
serious adverse events (SAEs); (2) non-serious AEs (as applicable); and (3) scenarios involving 
drug exposure , including exposure during pregnancy, exposure during breast feeding, 
medication error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure. 
These events are defined in the section “Definitions of safety events”. 
Safety event
Recorded on the CRF
Reported on the NIS AEM Report 
Form to Pfizer Safety within 24 hours 
of awareness
SAE
All 
All
Non-serious AE
All 
None
Scenarios involving 
exposure to a drug under 
study, including exposure 
during pregnancy, exposure 
during breast feeding, 
medication error, overdose, 
misuse, extravasation, lack 
of efficacy, and 
occupational exposure
All (regardless of whether 
associated with an AE), 
except occupational 
exposure
All (regardless of whether associated 
with an AE)
Note: Any associated AE is reported 
together with the exposure scenario.
For each AE, the investigator must pursue and obtain information adequate both to determine the 
outcome of the AE and to assess whether it meets the criteria for classification as a SAE (refer to
section “Serious Adverse Events” below).
Safety events listed in the table above must be reported to Pfizer within 24 hours of awareness of 
the event by the investigator regardless of whether the event is determined by the 
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investigator to be related to this drug. In particular, if the SAE is fatal or life-threatening, 
notification to Pfizer must be made immediately, irrespective of the extent of available event 
information. This timeframe also applies to additional new (follow-up) information on 
previously forwarded safety event reports. In the rare situation that the investigator does not 
become immediately aware of the occurrence of a safety event, the investigator must report the 
event within 24 hours after learning of it and document the time of his/her first awareness of the 
events.
For safety events that are considered serious or that are identified in the far-right column of the 
table above that are reportable to Pfizer within 24 hours of awareness, the investigator is
obligated to pursue and to provide any additional information to Pfizer in accordance with this 
24-hour timeframe. In addition, an investigator may be requested by Pfizer to obtain specific 
follow-up information in an expedited fashion. This information is more detailed than that 
recorded on the CRF. In general, this will include a description of the AE in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of possible 
causality. Any information relevant to the event, such as concomitant medications and illnesses 
must be provided. In the case of a patient death, a summary of available autopsy findings must 
be submitted as soon as possible to Pfizer or its designated representative. 
10.2. Reporting period 
For each patient, the safety event reporting period begins at the time of the patient’s first dose of 
this drug and lasts through the end of the observation period of the study, which must include at 
least 56 calendar days following the last administration of a drug under study; a report must be 
submitted to Pfizer Safety (or its designated representative) for any of the types of safety events 
listed in the table above occurring during this period. If a patient was administered a drug under 
study on the last day of the observation period, then the reporting period should be extended for 
56 calendar days following the end of observation.
If the investigator becomes aware of a SAE occurring at any time after completion of the study 
and s/he considers the SAE to be related to this drug, the SAE also must be reported to Pfizer 
Safety.
10.3. Causality assessment
The investigator is required to assess and record the causal relationship. For all AEs, sufficient 
information should be obtained by the investigator to determine the causality of each AE. For 
AEs with a causal relationship to this drug, follow-up by the investigator is required until the 
event and/or its sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer 
concurs with that assessment.
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An investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that this drug caused or contributed to an AE. If the investigator’s final determination 
of causality is “unknown” and s/he cannot determine whether this drug caused the event, the 
safety event must be reported within 24 hours. 
If the investigator cannot determine the etiology of the event but s/he determines that this drug
did not cause the event, this should be clearly documented on the CRF and the NIS AEM Report 
Form.
10.4. Definitions of safety events
10.4.1. Adverse events
An AE is any untoward medical occurrence in a patient administered a medicinal product. The 
event need not necessarily have a causal relationship with the product treatment or usage.
Examples of AEs include but are not limited to:  

Abnormal test findings (see below for circumstances in which an abnormal test finding 
constitutes an AE);

Clinically significant signs and symptoms;

Changes in physical examination findings;

Hypersensitivity;

Progression/worsening of underlying disease;

Lack of efficacy; 

Drug abuse; 

Drug dependency.
Additionally, for medicinal products, they may include the signs or symptoms resulting from:

Drug overdose;

Drug withdrawal;

Drug misuse;

Off-label use; 

Drug interactions;
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
Extravasation;

Exposure during pregnancy;

Exposure during breast feeding;

Medication error;

Occupational exposure.
Abnormal test findings
The criteria for determining whether an abnormal objective test finding should be reported as an 
AE are as follows: 

Test result is associated with accompanying symptoms, and/or

Test result requires additional diagnostic testing or medical/surgical intervention, and/or

Test result leads to a change in study dosing or discontinuation from the study, significant 
additional concomitant drug treatment, or other therapy, and/or

Test result is considered to be an AE by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an AE. Any abnormal test result that is determined to be an error does not require 
reporting as an AE.
10.4.2. Serious adverse events
A SAE is any untoward medical occurrence in a patient administered a medicinal or nutritional 
product (including pediatric formulas) at any dose that:

Results in death;

Is life-threatening;

Requires inpatient hospitalization or prolongation of hospitalization (see below for 
circumstances that do not constitute AEs);

Results in persistent or significant disability/incapacity (substantial disruption of the ability 
to conduct normal life functions);

Results in congenital anomaly/birth defect.
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Medical and scientific judgment is exercised in determining whether an event is an important 
medical event. An important medical event may not be immediately life-threatening and/or result 
in death or hospitalization. However, if it is determined that the event may jeopardize the patient
or may require intervention to prevent one of the other outcomes listed in the definition above, 
the important medical event should be reported as serious.
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or 
development of drug dependency or drug abuse.
Additionally, any suspected transmission via a Pfizer product of an infectious agent, pathogenic 
or non-pathogenic, is considered serious. The event may be suspected from clinical symptoms or 
laboratory findings indicating an infection in a patient exposed to a Pfizer product. The terms 
“suspected transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance (PV)
personnel. Such cases are also considered for reporting as product defects, if appropriate.
Hospitalization
Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or 
equivalent healthcare facility or any prolongation to an existing admission. Admission also 
includes transfer within the hospital to an acute/intensive care unit (e.g., from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, neurological floor to a tuberculosis 
unit). An emergency room visit does not necessarily constitute a hospitalization; however, an 
event leading to an emergency room visit should be assessed for medical importance. 
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable. For 
example, the following reports of hospitalization without a medical AE are not to be reported. 

Social admission (e.g., patient has no place to sleep)

Administrative admission (e.g., for yearly exam)

Optional admission not associated with a precipitating medical AE (e.g., for elective 
cosmetic surgery)

Hospitalization for observation without a medical AE

Admission for treatment of a pre-existing condition not associated with the development of a 
new AE or with a worsening of the pre-existing condition (e.g., for work-up of persistent pre-
treatment lab abnormality)
10.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours
Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication 
error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure are described 
below.
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Exposure during pregnancy
An exposure during pregnancy (EDP) occurs if:
1. A female becomes, or is found to be, pregnant either while receiving or having been exposed
to (e.g., environmental) this drug, or the female becomes, or is found to be, pregnant after 
discontinuing and/or being exposed to this drug (maternal exposure).
An example of environmental exposure would be a case involving direct contact with a Pfizer 
product in a pregnant woman (e.g., a nurse reports that she is pregnant and has been exposed to 
chemotherapeutic products).
2.
A male has been exposed, either due to treatment or environmental exposure to this drug
prior to or around the time of conception and/or is exposed during the partner pregnancy 
(paternal exposure).
For exposure during pregnancy in studies of pregnant women, data on the exposure to drug
during pregnancy, are not reportable unless associated with serious or non-serious adverse 
events.
As a general rule, prospective and retrospective exposure during pregnancy reports from any 
source are reportable irrespective of the presence of an associated AE and the procedures for 
SAE reporting should be followed, with the exception of those studies conducted in pregnant 
women (as described in above), for which data on the exposure are not reportable unless
associated with serious or non-serious adverse events. 
If a study participant or study participant’s partner becomes, or is found to be, pregnant during 
the study participant’s treatment with this drug, this information must be submitted to Pfizer, 
irrespective of whether an AE has occurred using the NIS AEM Report Form and the EDP 
Supplemental Form. 
In addition, the information regarding environmental exposure to this drug, in a pregnant woman 
(e.g., a patient reports that she is pregnant and has been exposed to a cytotoxic product by 
inhalation or spillage) must be submitted using the NIS AEM Report Form and the EDP 
Supplemental Form. This must be done irrespective of whether an AE has occurred. 
Information submitted should include the anticipated date of delivery (see below for information 
related to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy; in addition, follow-up is 
conducted to obtain information on EDP outcome for all EDP reports with pregnancy outcome 
unknown. A pregnancy is followed until completion or until pregnancy termination (e.g., 
induced abortion) and Pfizer is notified of the outcome. This information is provided as a follow 
up to the initial EDP report. In the case of a live birth, the structural integrity of the neonate can 
be assessed at the time of birth. In the event of a termination, the reason(s) for termination should 
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be specified and, if clinically possible, the structural integrity of the terminated fetus should be 
assessed by gross visual inspection (unless pre-procedure test findings are conclusive for a 
congenital anomaly and the findings are reported).
If the outcome of the pregnancy meets the criteria for an SAE (e.g., ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a live 
born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the procedures for 
reporting SAEs should be followed.
Additional information about pregnancy outcomes that are reported as SAEs follows: 

Spontaneous abortion includes miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when 
the investigator assesses the infant death as related or possibly related to exposure to 
investigational product.
Additional information regarding the exposure during pregnancy may be requested. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (e.g., follow-up on preterm 
infants to identify developmental delays). 
In the case of paternal exposure, the study participant will be provided with the Pregnant Partner 
Release of Information Form to deliver to his partner. It must be documented that the study 
participant was given this letter to provide to his partner.
Exposure during breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of an 
associated AE. An exposure during breastfeeding report is not created when a Pfizer drug 
specifically approved for use in breastfeeding women (e.g., vitamins) is administered in accord 
with authorized use. However, if the infant experiences an AE associated with such a drug’s 
administration, the AE is reported together with the exposure during breastfeeding.
Medication error
A medication error is any unintentional error in the prescribing, dispensing or administration of a 
medicinal product that may cause or lead to inappropriate medication use or patient harm while 
in the control of the health care professional, patient, or consumer. Such events may be related to 
professional practice, health care products, procedures, and systems including: prescribing; order 
communication; product labeling, packaging, and nomenclature; compounding; dispensing; 
distribution; administration; education; monitoring; and use. 
Medication errors include:
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
Near misses, involving or not involving a patient directly (e.g., inadvertent/erroneous 
administration, which is the accidental use of a product outside of labeling or prescription on 
the part of the healthcare provider or the patient/consumer);

Confusion with regard to invented name (e.g., trade name, brand name).
The investigator must submit the following medication errors to Pfizer, irrespective of the 
presence of an associated AE/SAE:

Medication errors involving patient exposure to the product, whether or not the medication 
error is accompanied by an AE.

Medication errors that do not involve a patient directly (e.g., potential medication errors or 
near misses). When a medication error does not involve patient exposure to the product the 
following minimum criteria constitute a medication error report:

An identifiable reporter;

A suspect product;

The event medication error.
Overdose, Misuse, Extravasation
Reports of overdose, misuse, and extravasation associated with the use of a Pfizer product are 
reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE.
Lack of Efficacy
Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the investigator, 
irrespective of the presence of an associated AE/SAE or the indication for use of the Pfizer 
product.
Occupational Exposure
Reports of occupational exposure to a Pfizer product are reported to Pfizer by the investigator,
irrespective of the presence of an associated AE/SAE.
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
Information collected in this study will be used for reporting purposes to report Ministry of 
Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), 
Pfizer Inc. which is the corporate parent of the sponsor of this study, and the group companies, or 
regulatory agency in other countries. Also, it will be used for submitting application of re-
examination (including Periodic Safety Update Report), re-evaluation, preparation of material for 
proper use information of this drug, publications and activities for information provision. In 
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addition, Pfizer may disclose the study results to provide information for proper use, as needed, 
on www.clinicaltrials.gov (ClinicalTrials.gov), as presentations at academic conferences, or as 
manuscripts, etc.
Data obtained from the patients registered in this Study will be reported to the MHLW pursuant 
to the Pharmaceutical and Medical Device Act. In this case, the data may be publicly posted in 
MHLW's “Pharmaceutical and Medical Device Safety Information” and “Pharmaceuticals and 
Medical Devices Information Website (http://www.info.pmda.go.jp)” as a listing of patients, 
which will include the names of drugs, adverse reactions, gender, age (increment of 10 years), 
and other relevant information. Furthermore, data collected may also be disclosed if the MHLW 
is required to disclose such information in accordance with the “Act on Access to Information 
Held by Administrative Organs” (Law No. 42 dated May 14, 1999); provided that in no event 
will the names of physicians, medical institutions, and other personal information be subject to 
such disclosure, nor will it be posted or disclosed.
In the event of any prohibition or restriction imposed (e.g., clinical hold) by an applicable 
Competent Authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of a Pfizer product, 
Pfizer should be informed immediately. 
12. NAME, AND ADDRESS OF CONTRACTOR AS WELL AS SCOPE OF WORK 
CONTRACTED
Company name: Pfizer R&D Japan
Address: 3-22-7, Yoyogi, Shibuya-ku, Tokyo
Scope of work contracted: Works related to planning of study, drafting of plan, implementation 
of study and monitoring, etc.
Company name: Medidata Solutions 
Address: 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
Scope of work contracted: Construction of EDC, duties related to administration, etc.
Company name: A2 Healthcare Corporation
Address: 1-4-1 Koishikawa, Bunkyo-ku, Tokyo
Scope of work contracted: Contract duties, reception of registration form, delivery and receipt of 
CRF, etc.
Company name: EPS Corporation
Address: 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
Scope of work contracted: Construction of EDC, data management duties, analysis duties
13. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON THE 
STUDY RESULTS AND CRITERIA FOR DETERMINATION OF THE INITIATION
Review the risk management plan including the following contents at the scheduled timing of 
milestones.
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
Review the necessity for changing the contents of risk minimization activities for the 
current safety specifications.

Review the necessity for changing the contents of this study plan including the presence 
or absence of new safety specifications (continuation of the study, implementation of 
additional study, etc.).

Review the necessity for formulating risk minimization measures for new safety 
specifications.
14. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
EVALUATION OF STUDY IMPLEMENTATION STATUS AND RESULTS AND 
REPORTING TO THE PMDA
Review and report the safety every year from approval to submission of the final report.
15. OTHER NECESSARY MATTERS
15.1. Amendment of the Study Protocol 
Based on the new knowledge to be obtained according to the progress of this study, the need for 
amendment of the protocol will be examined and the Study Protocol will be amended if 
necessary. Also, the need for amendment of the Study Protocol will be examined and the 
protocol will be amended when the partial change in the dosage and administration or indication 
is approved during the reexamination period (except when the reexamination period is newly 
designated), etc.
15.2. Actions to be taken for any problem or issue
Revision of the package insert and conduct of a new Post-marketing surveillance or new Post-
marketing Clinical Trial should be considered for the following cases: any serious and unknown 
adverse reaction is suggested; a significant increase in the frequency of adverse reactions; any 
effectiveness or safety concern compared to pre-approval; rare adverse reaction is suggested. 
16. CONTACT INFORMATION
16.1. Contact information for inquiries about the study
Name
PMS Affairs, Pfizer R&D Japan 
Address
Shinjuku Bunka Quint Building, 3-22-7, Yoyogi, Shibuya-ku, 
Tokyo 151-8589
E-mail address
IFX_PMS@pfizer.com
16.2. Contact information for inquiries about the EDC system 
Name
Medidata Helpdesk
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Business Hours
Weekday 9:00-20:00 (excluding Saturdays, Sundays and holidays,
Year-end and New Year holidays)
TEL
0800-222-2099 (dedicated to Pfizer)
E-mail address
japanhelpdesk@mdsol.com
17. REFERENCES
Not applicable
18. LIST OF TABLES 
Table 1 Observation Items and Schedule
19. LIST OF FIGURES
Not applicable
ANNEX 1. LIST OF STAND ALONE DOCUMENTS
Not applicable
ANNEX 2. ADDITIONAL INFORMATION
Not applicable
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Page 1 of 1
TRANSLATION RECORD
(FOR POST-MARKETING SURVEILLANCE STUDY IN JAPAN)
10-Jan-2019
Document Type
Protocol
Document Date 
(Original)
18 Oct 2022
Program
B537
Study
B5371009
Original Language
Japanese
Site
NA
Translation Language
English
Is a back 
translation
required?
NO
FULL TRANSLATION AND REVIEW INFORMATION
Translator Qualification 
Type
Internal Pfizer employee
Translation Vendor N/A
Translator Name
Date of Translation
15 Jan 2025
Reviewer Name
Date of Review
15 Jan 2025
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PPD
PPD