DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES
Conditions: Depression/Depressed State
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 1 of 32
DRUG USE INVESTIGATION OF EFFEXOR® SR
CAPSULES
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 o
any actual or suspected breach of this obligation, Pfizer must be promptly notified.

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Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 3 of 32
TABLE OF CONTENTS
1. LIST OF ABBREVIATIONS................................................................................................6
2. RESPONSIBLE PARTIES....................................................................................................7
3. AMENDMENTS AND UPDATES.......................................................................................8
4. MILESTONES.....................................................................................................................10
5. RATIONALE AND BACKGROUND................................................................................10
6. RESEARCH QUESTION AND OBJECTIVES .................................................................10
6.1. Safety specifications................................................................................................10
6.2. Other safety investigation item ...............................................................................11
7. RESEARCH METHODS ....................................................................................................11
7.1. Study design ............................................................................................................11
7.2. Setting......................................................................................................................11
7.2.1. Inclusion criteria .........................................................................................11
7.2.2. Exclusion criteria........................................................................................12
7.2.3. Study sites...................................................................................................12
7.2.4. Planned study period...................................................................................12
7.2.5. Study method..............................................................................................12
7.2.6. Observation period......................................................................................12
7.3. Variables..................................................................................................................13
7.3.1. Patient Background.....................................................................................15
7.3.2. Administration record of targeted drug (actual dosing record) ..................16
7.3.3. Discontinuation record................................................................................16
7.3.4. Previous treatments and concomitant drug therapies for 
depression/depressive state..............................................................................17
7.3.5. Other concomitant drug therapies...............................................................17
7.3.6. Previous and concomitant non-drug therapies for 
depression/depressive state..............................................................................17
7.3.7. Tests............................................................................................................17
7.3.8. Clinical assessments ...................................................................................17
7.3.9. Clinical global impressions (CGI)..............................................................18
7.3.10. Pregnancy status .......................................................................................19
7.3.11. Confirmation of presence or absence of safety specifications and 
adverse events corresponding to other safety specifications ...........................19
7.3.12. Adverse events..........................................................................................19

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 4 of 32
7.3.13. Major investigation items .........................................................................20
7.4. Data sources ............................................................................................................20
7.5. Target sample size...................................................................................................20
7.5.1. Planned sample size....................................................................................20
7.5.2. Rationale for sample size............................................................................20
7.6. Data management....................................................................................................21
7.6.1. Data collection method...............................................................................21
7.6.2. Patient registration......................................................................................21
7.6.3. Reminders concerning completion, revision, and submission of case 
report form .......................................................................................................21
7.7. Data analysis ...........................................................................................................21
7.8. Quality control.........................................................................................................22
7.9. Limitations of the research methods .......................................................................22
7.10. Other aspects .........................................................................................................22
8. PROTECTION OF HUMAN SUBJECTS ..........................................................................22
8.1. Patient information and consent..............................................................................22
8.2. Patient withdrawal criteria and procedure...............................................................22
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............22
8.4. Ethical conduct of the study....................................................................................23
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................23
9.1. Requirement ............................................................................................................23
9.2. Reporting period......................................................................................................24
9.3. Causality assessment...............................................................................................24
9.4. Definitions of safety events.....................................................................................24
9.4.1. Adverse events............................................................................................24
9.4.2. Serious adverse events................................................................................26
9.4.3. Scenarios reportable to Pfizer Safety within 24 hours................................27
9.5. Single reference safety document............................................................................29
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........29
11. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION...........................29
12. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON 
WHO WAS CONTRACTED WITH THE OPERATIONS ...............................................29

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Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 6 of 32
1. LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
Adverse event
ALT
Alanine transaminase
Al-P
Alkaline phosphatase
AST
Aspartate transaminase
BUN
Blood urea nitrogen
CGI
Clinical Global Impressions
CGI-I
Clinical Global Impressions-Improvement
CGI-S
Clinical Global Impressions-Severity
CPK
Creatine phosphokinase
EM
Extensive metabolizer
γ-GTP
γ-glutamyl transpeptidase
GGT
γ-glutamyl transpeptidase
GOT
Glutamate oxaloacetate transaminase
GPT
Glutamate pyruvate transaminase
HAM-D
Hamilton Rating Scale for Depression
HbA1c
Hemoglobin A1c
HDL
High-density lipoprotein
IDS-C
Inventory of Depressive Symptomatology-Clinician Rating
IM
Inter mediate metabolizer
IRB
Institutional review board
LDH
Lactate dehydrogenase isozyme
LDL
Low-density lipoprotein
IEC
Independent Ethics Committee
MADRS
Montgomery - Asberg Depression Rating Scale(MADRS)
N/A
Not applicable
NIS
Non interventional study
PHQ
Patient Health Questionnaire
PM
Poor metabolizer
QIDS-SR
Quick Inventory of Depressive Symptomatology-Self Report
SAE
Serious adverse event
SIGMA
Structured Interview Guide for MADRS
SRSD
Single Reference Safety Document
TG
Triglyceride
UM
Ultra-rapid metabolizer
USPI
United States package insert

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 7 of 32
2. RESPONSIBLE PARTIES
The Japan Good Post Marketing Study Practice Officer
Principal Investigator(s) of the Protocol
N/A

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 8 of 32
3. AMENDMENTS AND UPDATES
Amendm
ent
number
Date
Amendment of
the
plan/Others
Amended 
section
Summary of
amendment(s)
Reason
Amended 
Version
2
2018/12/1
Others
9.4.
Definitions of
safety events
Change in
description
associated with the
revision of 9.4.1.
Adverse events
For description
adjustment
Amended 
Version
2
2018/12/1
Others
9.4.1.
Adverse events
Change in
description from
“Drug
discontinuation” to
“Drug withdrawal”
For description
adjustment
Amended 
Version
2
2018/12/1
Others
12.
NAME,
ADDRESS AND
OUTSOURCED
OPERATIONS
OF THE
PERSON WHO
WAS
CONTRACTED
WITH THE
OPERATIONS
Addition associated
with the
establishment of
Pfizer R&D Japan
G.K.
For description
adjustment
Amended 
Version
2
2018/12/1
Others
16.1
Contact
information for
the contents of
the study
Revision associated
with the
establishment of
Pfizer R&D Japan
G.K.
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.2.
Setting
Change in
description
associated with the
revision of 7.2.2.
Exclusion criteria
For description
adjustment
Amended 
Version
1
2016/1/6
Revision of the
plan
7.2.1.
Inclusion criteria
It was specified that
patients with no
prior exposure to
this product will be
included in this
study.
For the revision
of the plan
Amended 
Version
1
2016/1/6
Revision of the
plan
7.2.2.
Exclusion
criteria
Exclusion criteria
were reviewed
because it is not
appropriate to set
exclusion criteria in
drug use
investigations.
For the revision
of the plan
Amended 
Version
1
2016/1/6
Revision of the
plan
7.2.3.
Study sites
Main departments
for the conduct of
this study were
reviewed, and
neurology was
For the revision
of the plan

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 9 of 32
deleted.
Amended 
Version
1
2016/1/6
Others
7.3.
Variables
Addition associated
with the revision of
7.2.1. Inclusion
criteria
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.3.1.
Patient 
Background 1)
Addition associated
with the revision of
7.2.1. Inclusion
criteria
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.3.1.
Patient 
Background
Reference) 
Rough guide for
determination on
the severity of
renal impairment
Test item
The description
“Symptom, etc.”
was changed to
“Other symptom,
etc.”
For the
modification of
a clerical error
Amended 
Version
1
2016/1/6
Others
7.3.8.1.
HAM-D
The source of the
assessment results
items of the
investigation form
was specified in a
separate section.
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.3.8.2.
MADRS
The source of the
assessment results
items of the
investigation form
was specified in a
separate section.
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.3.9.2.
Overall
improvement
(CGI-I)
A direction that the
reason for
“unevaluable”
should be entered if
the assessment
cannot be made was
added.
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.5.1.
Planned sample
size
“3 months” was
changed to “12
weeks.”
For description
adjustment
Amended 
Version
1
2016/1/6
Others
7.5.2.
Rationale for
sample size
“3 months” was
changed to “12
weeks.”
For description
adjustment
Amended 
Version
1
2016/1/6
Others
21.
ADDITIONAL
INFORMATION
The sources of the
assessment results
items of the
investigation form
were transferred to
this section.
For description
adjustment
Initial
protocol
2015/10/2
1
N/A
N/A
N/A
N/A

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 10 of 32
4. MILESTONES
5. RATIONALE AND BACKGROUND
Effexor® SR Capsules 37.5 mg and 75 mg (Generic name: Venlafaxine Hydrochloride) (hereinafter
referred to as this product) is a sustained-release preparation of venlafaxine hydrochloride (1-[2-
(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol-HCl) and antidepressant which is classified
into a serotonin-noradrenaline reuptake inhibitor (SNRI). In Japan, the application for approval of
marketing authorization was filed in December 2014 for the indication of “depression and depressive
state.”
The “Drug Use Investigation of Effexor® SR Capsules” will be conducted to collect the safety and
efficacy information of this product. The information to be collected in this study will be used to
prepare and provide the materials for proper use information of this product.
The study will be conducted based on the “Ministerial Ordinance on Good Post-marketing Study
Practice for Drugs” (MHLW Ordinance No. 171 dated December 20, 2004). The case data to be
collected in this study will be also reported to the Ministry of Health, Labour and Welfare (MHLW) 
based on the Pharmaceutical and Medical Device Act.
In this case, the information such as drug name, name of adverse reaction, gender, and age (generation) 
for applicable case data may be made public as a list of cases on “Pharmaceuticals and Medical Devices
Safety Information” and “Supply of Information on Drugs and Medical Devices Website
(http://www.info.pmda.go.jp)” by the MHLW.
Furthermore, the collected case data will be also disclosed if any request to disclose the information is
made to the MHLW based on the “Act on Access to Information Held by Administrative Organs” (Act
No. 42 of May 14, 1999). However, the information on doctor’s name and site name will be neither
subject to reporting nor posted or disclosed in either case.
6. RESEARCH QUESTION AND OBJECTIVES
To confirm the safety and effectiveness of Effexor under actual medical practice. 
6.1. Safety specifications
Serotonin syndrome, Convulsion, Withdrawal syndrome, Increased blood pressure/Hypertensive
crisis/Increased heart rate, QT prolongation/Torsade de Pointes (TdP), Lipid effects,
Hyponatremia/Syndrome of inappropriate secretion of antidiuretic hormone (SIADH), Stevens-Johnson
syndrome (SJS)/Toxic Epidermal Necrolysis (TEN)/Erythema multiforme, Anaphylaxis, Urinary
retention, Suicidal ideation/Suicide attempt, Mania/Hypomania, Abnormal Bleeding: ecchymoses,
hematomas, epistaxis, and petechiae leading to life-threatening hemorrhage, Hostility/Aggression,
Ischaemic heart disease, Agranulocytosis/Aplastic anaemia/Pancytopenia/Neutrophil count
decreased/Platelet count decreased, Interstitial lung disease (ILD), Noradrenaline effect potentiation by
increase in dosage (Insomnia, Blood pressure increased, etc.), Safety in the patient with mild or
moderate hepatic impairment, Safety in the patient with mild or moderate renal impairment.
Milestone
Planned date
Start of data collection
April 2016
End of data collection
March 2020
Final study report
December 2020

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Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 12 of 32
7.2.2. Exclusion criteria
Exclusion criteria are not provided in this study.
7.2.3. Study sites
The study will be conducted at 150 to 200 sites including the departments of psychiatry, psychosomatic
medicine, internal medicine, and neurological science.
7.2.4. Planned study period
This planned period covered by this study is as follows.
Investigation period: April 2016 to March 2020
Registration period: April 2016 to March 2019
(The registration will be completed if a target sample size has been reached even prior to completion of the
registration period)
7.2.5. Study method
This study will be conducted under the central registration system until the number of subjects who
meet the conditions for registration reaches the number of contract subjects.
7.2.6. Observation period
Twelve weeks from the start date. The patients who completed the 12-week treatment with this product
will be observed up until Week 52.
This study will be conducted using the separate-type case report forms. The results of observation
during the following observation periods will be entered to each case report form. However, the
information from the date of last treatment until 28 days later will be collected for patients who
discontinued this product.
Figure 1. Observation period for Each Booklet
Name of case report form
Observation period
Booklet 01
From the start date until Week 12
Booklet 02
From Week 13 after the start of treatment with this product until
Week 52
Booklet 01
(Observation period: until
Week 12)
Booklet 02
(Observation period: from Week 13 to Week 52)
Start date
(Day 1)
Week 12
Week 52

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 13 of 32
7.3. Variables
This study will be conducted according to the following schedule of observation.
Table 1.
Schedule of observation
Registration form
Case report forms
                                               Timing  
Variables
At registration
Observation period
Booklet 01
Booklet 02
Before
administration
Start date of
administration
Week 12
Week 13 after
administration
Week 52
Backg
round
ID number (other than
Medical Chart Number)
●
Gender
●
Age (at the time when the
treatment with this product is
commenced)
●
Inclusion criteria
●
Start date of administration 
(Western calendar)
●
Height/Weight
●
Hospitalization status
(inpatient/outpatient)
●
Disease to be
studied/duration of disease
●
Depression phase (initial
onset/relapse)
●
Duration of the latest episode
●
Presence or absence and
severity of hepatic
impairment
●
Presence or absence and
severity of renal impairment
●
Drinking status
●
Medical history (prior and
present)
●
Presence or absence of past
suicidal ideation or suicide
attempt
●
Targeted drug use record (actual
dosing record)
Discontinuation record
   ●1)
   ●1)
Prior medications/concomitant drug
therapies for depression/depressive
state
Other concomitant drug therapies
Prior and concomitant non-drug
therapies for depression/depressive
state
Blood pressure/pulse rate (sitting
position)
CYP2D6 metabolizing-enzyme
expression type2)

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 14 of 32
Laboratory test (blood test)
Clinical assessment (HAM-D)
Clinical assessment (MADRS)
Overall severity (CGI-S)
Overall improvement (CGI-I)
Presence or absence of pregnancy
(only for women)
Confirmation of presence or absence
of safety specifications and adverse
events corresponding to other safety
specifications
Adverse events (all adverse events)
1) If the study was not continued until completion of the observation period of this case report form
2) If the investigator has obtained the information on CYP2D6 by PM/IM/EM/UM in daily medical practice

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
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Pfizer Confidential
Page 15 of 32
7.3.1. Patient Background
1) Input the information at the commencement of this product into the registration form
1.
ID number (other than Medical Chart Number)
2.
Gender (male/female)
3.
Age (at the time when the treatment with this product is commenced)
4.
Inclusion criteria
5.
Start date of this product (Western calendar)
2) Enter the following information at the start of treatment with this product in the case report form.
1.
Height (cm), Weight (kg)
2.
Hospitalization status (inpatient/outpatient)
3.
Disease to be studied (name of disease [diagnosis] indicated for treatment with this product) 
and duration of disease
4.
Depression phase (initial onset/relapse)
5.
Duration of the latest episode
6.
Presence or absence and severity of hepatic impairment: If the patient has hepatic impairment,
classify the severity with reference to the following criteria.
Reference) Rough guide for determination on the severity of hepatic impairment
Severity
Test item
Mild
Moderate
Severe
Total bilirubin
(mg/dL)
≥1.6 - <3.0
≥3.0 - <10
≥10
GOT, GPT
(U)
≥1.25×N - <2.5×N
≥50 - <100
≥2.5×N - <12×N
≥100 - <500
≥12×N
≥500
Al-P
≥1.25×N - <2.5×N
≥2.5×N - <5×N
≥5×N
γ-GTP
≥1.5×N
―
―
LDH
≥1.5×N
―
―
PT
―
―
≤40%
Symptom, etc.
―
Jaundice
Hepatomegaly
Hypochondrium pain right
Hepatic steatosis
Bleeding tendency,
symptoms of hepatic failure
such as consciousness
disturbed (fulminant
hepatitis),
cirrhosis, liver tumor,
jaundice that persists for
more than 6 months
N: Upper limits of normal (ULN) for each site
(Source: Classification Criteria for Severity of Adverse Reactions, Notification No. 80 of the
PAB/Safety Division dated June 29, 1992)
7.
Presence or absence and severity of renal impairment: If the patient has renal impairment,
classify the severity with reference to the following criteria.
Reference) Rough guide for determination on the severity of renal impairment
Severity
Test item
Mild
Moderate
Severe
BUN
(mg/dl)
>1×N - <25
≥25 - <40
≥40
Creatinine (mg/dL)
>1×N - <2
≥2 - <4
≥4
Urine protein
1+
2+ - 3+
>3+
Hematuria
Microscopic
Gross
Gross, clot
Urine output
―
≤500 mL/24 hr or
oliguria/polyuria*
≤100 mL/24 hr or anuria
Serum potassium
―
≥5.0 - <5.5
≥5.5

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 16 of 32
( mEq /l )
Other symptom,
etc.
―
―
Nephrotic syndrome
Acute renal failure
(interstitial nephritis, tubular
necrosis, renal necrosis,
renal papillary necrosis,
renal cortical necrosis)
Chronic renal failure
(interstitial nephritis, tubular
necrosis, renal necrosis,
renal papillary necrosis,
renal cortical necrosis)
Uremia
Hydronephrosis
N: Upper limits of normal (ULN) for each site
Note) *Polyuria: Refer to the case of nephrogenic diabetes insipidus
(Source: Classification Criteria for Severity of Adverse Reactions, Notification No. 80 of the
PAB/Safety Division dated June 29, 1992)
Important supplementary information: Hepatic impairment/renal impairment refer to an event that requires clinical
attention and follow-up rather than a transient laboratory test abnormality.
8.
Drinking status (frequency of drinking, amount of drinking per day)
9.
Medical history (information on diseases other than those to be studied): Enter chronic
diseases (including allergy), diseases that require treatment, diseases or disorders
accompanied by surgery, hospitalization and/or sequela, and other potentially significant
diseases or syndromes. Enter “prior” if the disease had been cured prior to the start of
treatment with this product and “present” if the patient is being affected at the start of
treatment with this product. However, enter the details in the adverse event section if the
patient was affected with or developed the disease after the start date of treatment with this
product.
10. Presence or absence of past suicidal ideation or suicide attempt
7.3.2. Administration record of targeted drug (actual dosing record)
Enter the dose, frequency of daily dosing, and treatment period of this product from the start date of
treatment until the end date of observation period in this case report form (Week 12 and Week 52, or
last date of treatment with this product if the treatment is discontinued). If there is any change in the
dose and frequency of daily dosing, or if the treatment with this product is temporarily interrupted
(washout), enter the “reason for change/washout” together.
1.
Reason for change/cessation of this drug
2.
Daily dose
3.
Number of doses per day
4.
Treatment period
7.3.3. Discontinuation record
If the study was not continued until the completion of observation period in this case report form, select
the reason from the following choices and enter it as the record of study discontinuation. If “Adverse
event” is chosen as the reason, enter the details in the adverse event section. If “Other” is selected, enter
the reason as well.
1.
Insufficient clinical effectiveness
2.
Adverse event
3.
No re-visit
4.
Other
(Enter the reason for “Other”; for example, patient’s will not related to adverse event, etc.)

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 17 of 32
7.3.4. Previous treatments and concomitant drug therapies for depression/depressive state
Enter the medications other than this product used for the treatment of depression/depressive state from
4 weeks prior to the start date of treatment with this product until the last date of observation period in
this case report form (Week 12 and Week 52, or 28 days after the last date of treatment with this
product if the treatment is discontinued).
1. Drug name (product name)
2. Route of administration
3. Daily dose
4. Treatment period
7.3.5. Other concomitant drug therapies
Enter other medications (medications other than those used for the treatment of depression/depressive
state) used from the start date of treatment with this product until the last date of observation period in
this case report form (Week 12 and Week 52, or 28 days after the last date of treatment with this
product if the treatment is discontinued).
1. Drug name (product name)
2. Route of administration
3. Treatment period
7.3.6. Previous and concomitant non-drug therapies for depression/depressive state
Enter the non-drug therapies given from 4 weeks prior to the start date of treatment with this product
until the last date of observation period in this case report form (Week 12 and Week 52, or 28 days after
the last date of treatment with this product if the treatment is discontinued).
1. Name of non-drug therapy
2. Duration of non-drug therapy
7.3.7. Tests
Enter the test results for clinical course from baseline (before the start of treatment with this product)
until the last date of observation period in this case report form (Week 12 and Week 52, or 28 days after
the last date of treatment with this product if the treatment is discontinued). For the entry of test results
before the start of treatment with this product, enter the results of the tests conducted immediately prior
to the start of treatment (including the start date of treatment). For the entry of test results during the
follow-up period, enter the test dates and items tested. For clinically significant abnormal fluctuations of
test values compared with baseline, enter the details in the adverse event section.
7.3.7.1. Blood pressure/pulse rate (sitting position)
1. Blood pressure (systolic and diastolic blood pressure)
2. Pulse rate
7.3.7.2. CYP2D6 metabolizing-enzyme expression type
If the investigator has obtained the information on CYP2D6 by PM/IM/EM/UM in daily medical
practice, enter the results.
7.3.7.3. Laboratory test (blood test)
Items to be entered: WBC count, platelet count, hemoglobin, AST (GOT), ALT (GPT), LDH, GGT (γ-
GTP), Al-P, CK (CPK), total bilirubin, BUN, serum creatinine, sodium, triglycerides (TG), total
cholesterol, HDL cholesterol, LDL cholesterol, fasting blood glucose, HbA1c
7.3.8. Clinical assessments
Enter the results of clinical assessment obtained from the following rating scales.

Effexor SR
B2411278 NON-INTERVENTIONAL STUDY PROTOCOL
Amended2, 01 December 2018
Pfizer Confidential
Page 18 of 32
7.3.8.1. HAM-D
As a clinical assessment, enter the assessment results of 17 items for the Hamilton Rating Scale for
Depression (HAM-D17). Among the assessments conducted within 4 weeks prior to the start of
treatment with this product, enter the assessment results closest to the start date of treatment and results
of assessments conducted until the first visit after the end date of the observation period (Week 12 and
Week 52). If the treatment with this product is discontinued, enter the results of assessment conducted
on the start date of tapering. However, if there are no assessments during the applicable period, enter the
results of assessments close to the applicable period. Also, enter the assessment results if the subject had
the follow-up visits and assessments until the last date of observation period, and if the assessments
were conducted before and after each dose escalation. Assessments should be conducted approximately
4 weeks after dose escalation. However, if there are no assessments during the applicable period, enter
the results of assessments after dose escalation close to the applicable period.
1. Presence or absence of HAM-D rating (if “No” is selected for the rating prior to the treatment with
this product, enter the reason)
2. Rating date of HAM-D
3. Rating of each item of HAM-D
7.3.8.2. MADRS
As a clinical assessment, enter the assessment results of Montgomery - Asberg Depression Rating Scale
(MADRS). Among the assessments conducted within 4 weeks prior to the start of treatment with this
product, enter the assessment results closest to the start date of treatment and results of assessments
conducted until the first visit after the end date of the observation period (Week 12 and Week 52). If the
treatment with this product is discontinued, enter the results of assessment conducted on the start date of
tapering. However, if there are no assessments during the applicable period, enter the results of
assessments close to the applicable period. Also, enter the assessment results if the subject had the
follow-up visits and assessments until the last date of observation period, and if the assessments were
conducted before and after each dose escalation. Assessments should be conducted approximately 4
weeks after dose escalation. However, if there are no assessments during the applicable period, enter the
results of assessments after dose escalation close to the applicable period.
1. Presence or absence of MADRS rating (if “No” is selected for the rating prior to the treatment
with this product, enter the reason)
2. Rating date of MADRS
3. Rating of each item of MADRS
7.3.9. Clinical global impressions (CGI)
Enter the results of assessments obtained from the following rating scales for impressions by the
clinician (clinical global impressions).
7.3.9.1. Overall severity (CGI-S)
The CGI-S is a 7-point rating scale that rates the overall severity of an illness. The investigator enters
the assessment results before the start date of treatment with this product (within 4 weeks before the
start of treatment) and results of assessments conducted until the first visit after the end date of the
observation period (Week 12 and Week 52). If the treatment with this product is discontinued, enter the
results of assessment conducted on the start date of tapering. However, if there are no assessments
during the applicable period, enter the results of assessments close to the applicable period. Also, enter
the assessment results if the subject had the follow-up visits and assessments until the last date of
observation period, and if the assessments were conducted before and after each dose escalation.
Assessments should be conducted approximately 4 weeks after dose escalation. However, if there are no
assessments during the applicable period, enter the results of assessments after dose escalation close to
the applicable period.
1.
Presence or absence of CGI-S rating (if “No” is selected for the rating prior to the treatment
with this product, enter the reason)
2.
Rating date of CGI-S

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conducting this study for 1,200 subjects with the target sample size of 900 subjects who complete the
12-week treatment.
Based on the final tabulation of the special investigation (long-term use investigation) of Jzoloft Tablets
conducted by our company, there were 369 subjects (34.5%) who continuously used this product for 52
weeks among the 1,069 subjects included in the safety analysis2). Assuming the percentage of subjects
who continue to use this product at 30% based on the continuation rate for 52 weeks in the special
investigation of Jzoloft Tablets, it is considered that we can collect about 400 subjects who continue to
use this product for 52 weeks by conducting this study for 1,200 subjects.
1) Including some subjects who were registered as having panic disorder.
2) It is a similar drug and in the special investigation (long-term use investigation) of Jzoloft Tablets
conducted by our company, the contract for special investigation was concluded with some sites which
conducted the drug use investigation and, among the subjects registered in the drug use investigation, all
subjects who continued to receive the drug for 16 weeks or longer were registered. For this reason, the
target sample size was set to be 1,069 subjects by adding the subjects who discontinued the treatment
before Week 16 to those who were registered in the special investigation in order to derive the
continuation rate.
7.6. Data management
7.6.1. Data collection method
In this study, the data entry in the case report forms and data confirmation will be conducted by using
online electronic post-marketing data collection system (or EDC, hereinafter referred to as this system) 
provided by the sponsor.
7.6.2. Patient registration
The investigator enters the registration items in the patient registration screen in this system and sends
them after e-signing. The case registration must be conducted within 14 days including the start date of
treatment with this product.
7.6.3. Reminders concerning completion, revision, and submission of case report form
7.6.3.1. Data entry
The investigator confirms the investigation items, enters the data in this system based on the
information in medical charts, and sends them after e-signing.
7.6.3.2. Data revision
If there is any inquiry about the entry from the sponsor (re-investigation), the investigator confirms the
information in medical charts again, corrects and re-submits it when necessary.
7.6.3.3. Submission
The investigator should send the data promptly after the entry according to the procedures stipulated by
the sponsor.
7.7. Data analysis
1)
Definition of analysis set
The subjects who are confirmed to have received treatment with this product are included in the
safety analysis set. The subjects who are evaluable (those considered to have appropriate

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assessments) according to the analysis plan separately stipulated are included in the efficacy
analysis set.
2)
Analytical method
(1)
Safety analysis
For the safety analysis set, major analysis items include occurrence of major adverse reactions and
incidence of adverse reactions (percentage of patients with adverse events for which the causal
relationship with this product cannot be ruled out).
(2)
Efficacy analysis
For the efficacy analysis set, major analysis items include those prescribed in the sections of
clinical assessments and clinical global impressions (CGI).
The detailed method of statistical analysis for the data to be collected in this study will be described in
the statistical analysis plan of this study and kept by Pfizer. While a plan outlined in the protocol may be
changed in the statistical analysis plan, any important change in the definition or analysis of the primary
endpoint must be reflected in the revision of the protocol.
7.8. Quality control
Prior to the implementation of this study, the site staff will explain the contents of the protocol, etc. to
the investigator and request him/her to prepare a case report form based on the medical chart.
7.9. Limitations of the research methods
This study may have the following limitations.
1)
Since no control group is set in this study, there is a limitation in judgment on whether the risk of
onset of adverse events or adverse reactions increases with the drug administered.
2)
Since the background information on patients cannot be adequately collected in some cases,
consideration of confounding factor may be insufficient.
3)
Since this is the study to collect the medical chart information, the target data may not be collected
or missing.
7.10. Other aspects
N/A
8. PROTECTION OF HUMAN SUBJECTS
8.1. Patient information and consent
All the staff involved in this study must guarantee to protect the personal information of patients to be
investigated and make sure that any forms, reports, publications provided by Pfizer and other documents
that may be disclosed will not contain the names of patients unless otherwise required by laws. Pfizer
will keep high-level confidentiality and protect the personal information when transferring the data.
In this study, the information will be collected by transcribing the medical chart information described
in daily clinical practice. Since the information collected from the medical chart is anonymized and does
not contain the information that can identify an individual patient, the consent form will not be used.
8.2. Patient withdrawal criteria and procedure
N/A
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
The review by Institutional Review Board (IRB)/Independent Ethics Committee (IEC) is not mandatory
in this study.

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8.4. Ethical conduct of the study
Since this study is conducted within the scope of the “Ministerial Ordinance on Good Post-marketing
Study Practice for Drugs” (MHLW Ordinance No. 171 dated December 20, 2004), ethical conduct of
the study is not applicable.
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS
Handling of each event when the investigator becomes aware of any event related to the safety
information will be stipulated below.
An event that needs to be reported to the sponsor within 24 hours should be reported using the
designated AE report form (Non-Interventional Study AE Report Form, hereinafter referred to as “NIS
AE Report Form”).
The NIS AE Report Form will be handled as part of the case report form.
If any AE is observed, the investigator must take appropriate measures, quickly inform Pfizer
(hereinafter referred to as “sponsor”), and if the causal relationship with this product cannot be ruled
out, follow it until the AE or its sequela resolves or becomes stable to a degree considered acceptable by
the investigator and the sponsor.
Also, for patients with a serious adverse reaction or adverse reaction not described in the package insert,
etc., the detailed investigation will be conducted separately if the sponsor considers it necessary.
9.1. Requirement
The table below summarizes the requirements for recording safety events in the CRF and for reporting 
safety events by the NIS AE 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 
breastfeeding, medication error, overdose, misuse, extravasation, and occupational exposure. These 
events are defined in the section “Definitions of safety events.”
Safety events
Recorded on the data collection
tool (e.g. CRF) 
Reported on the NIS AE
Report Form to Pfizer Safety
within 24 hours of awareness
SAE
All
All
Non-serious AE
All
None
Scenarios involving exposure to this
product, 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)
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 investigator to be related
to a drug under study. 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

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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 time frame. 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 in the data collection tool (e.g.
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.
9.2. Reporting period
For each patient, the safety events 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 28
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 28 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.
9.3. 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.
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 in the data collection tool (e.g. CRF) and the NIS
AE Report Form.
9.4. Definitions of safety events
9.4.1. 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.

Abnormal test findings (see below for circumstances in which an abnormal test finding constitutes
an AE);

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
Clinically significant symptoms and signs;

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;

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 dosing or discontinuation of the treatment with this product,
significant additional concomitant drug treatment, or other therapy, and/or

Test result is considered to be an AE by the investigator or Pfizer.
Merely repeating an abnormal test result, 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.

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9.4.2. Serious adverse events
An 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.
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 any of the 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 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 another department or 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 hospitalization without a medical AE are not to be reported.

Social admission (e.g., patient/subject has no place to sleep)

Administrative admission (e.g., for yearly exam)

Optional admission not associated with a precipitating medical condition (e.g., for elective
cosmetic surgery)

Hospitalization for observation without a medical AE

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
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)

Protocol-specified admission during the study (e.g., for a test or procedure required by the study
protocol)
9.4.3. Scenarios reportable to Pfizer Safety within 24 hours
Scenarios involving exposure during pregnancy, exposure during breast feeding, medication error,
overdose, misuse, extravasation, lack of efficacy, and occupational exposure are described below.
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 a 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).
As a general rule, prospective and retrospective EDP reports from any source are reportable irrespective
of the presence of an associated AE and the procedures for SAE reporting should be followed.
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 AE Report Form and the EDP Supplemental Form.
In addition, the information regarding environmental exposure to this drug in a pregnant woman (e.g., a
subject reports that she is pregnant and has been accidentally exposed to a cytotoxic product by
inhalation or spillage) must be submitted using the NIS AE 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 is assessed at the time of
birth. In the event of a termination, the reason(s) for termination should 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

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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 is as 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 breast feeding
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 accordance 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 preventable event 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:

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;

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
A suspect product;

The event of 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.
9.5. Single reference safety document
A Single Reference Safety Document (SRSD) refers to a document that contains the information on the 
known safety profile. The package insert of this product will be the SRSD in this study. Pfizer Japan 
Inc. will evaluate the safety information reported by the investigator during the study period using the 
SRSD.
The investigator will also prescribe the drug and give the drug administration guidance based on the 
SRSD.
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
The study results may be published during scientific meetings, in research paper, etc. for the
purpose of providing proper use information, etc.
COMMUNICATION OF ISSUE
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 this product, Pfizer should be informed
immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures taken by the
investigator to protect the study patients against any immediate hazard, and of any serious breaches of
this study protocol that the investigator becomes aware of.
11. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION
It will be the same as Attachment "Organization system for post-marketing surveillance and equivalent
activities." Study Manager shall be the Director of Post Marketing Study Strategy and Management.
12. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON WHO WAS
CONTRACTED WITH THE OPERATIONS
Address: Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
Company name: Pfizer R&D Japan G.K.
Scope of subcontract: Operations concerning the planning of surveillance, preparation of draft plan,
operation, etc. of the surveillance
Address: 2-23 Shimomiyabi-cho, Shinjuku-ku, Tokyo

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