KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
Conditions: Major Depressive Disorder
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study information
Title
Korean Post Marketing Surveillance to 
observe effectiveness and safety of 
PRISTIQ® in patients with major 
depressive disorder
Protocol number
B2061143
Protocol version identifier
Amendment 4
Date of last version of protocol
29Mar2016
Active substance
PF-05212375
Medicinal product
PRISTIQ® (desvenlafaxine)
Research question and objectives
To identify any problems and questions with 
respect to the safety and effectiveness of 
PRISTIQ® during the post-marketing period 
as required by Ministry of Food and Drug 
Safety(MFDS)’s regulations.
Author
Pfizer Pharmaceuticals Korea Ltd.
Seoul, Korea, Republic of
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.
PPD

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TABLE OF CONTENTS
TABLE OF CONTENTS .........................................................................................................2
1. LIST OF ABBREVIATIONS................................................................................................4
2. RESPONSIBLE PARTIES....................................................................................................5
3. AMENDMENTS AND UPDATES.......................................................................................6
4. MILESTONES.......................................................................................................................7
5. RATIONALE AND BACKGROUND..................................................................................7
6. RESEARCH QUESTION AND OBJECTIVES ...................................................................8
7. RESEARCH METHODS ......................................................................................................8
7.1. Study Design .............................................................................................................8
7.2. Study Size..................................................................................................................8
7.3. Setting........................................................................................................................8
7.3.1. Inclusion criteria ...........................................................................................8
7.3.2. Exclusion criteria..........................................................................................9
7.3.3. Duration of the study ....................................................................................9
7.3.4. Dosage and administration ...........................................................................9
7.4. Study Procedures.......................................................................................................9
7.4.1. Information of institution............................................................................10
7.4.2. Patient information (Baseline)....................................................................10
7.4.3. Medical history...........................................................................................10
7.4.4. Recent past psychotropic medication .........................................................11
7.4.5. Administrative status for PRISTIQ® ..........................................................11
7.4.6. Concomitant medications ...........................................................................11
7.4.7. Blood Pressure............................................................................................12
7.4.8. Clinical laboratory ......................................................................................12
7.4.9. Effectiveness Evaluation ............................................................................12
7.4.10. Safety Evaluation......................................................................................13
7.5. Data Sources............................................................................................................20
7.5.1. Case report forms........................................................................................20
7.5.2. Record retention..........................................................................................20
7.6. Data Management ...................................................................................................20
7.7. Data Analysis ..........................................................................................................21

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7.7.1. Safety analysis ............................................................................................21
7.7.2. Effectiveness analysis.................................................................................21
7.7.3. Statistical consideration..............................................................................22
7.8. Quality Control........................................................................................................22
7.9. Limitations of the Research Methods......................................................................22
8. PROTECTION OF HUMAN SUBJECTS ..........................................................................22
8.1. Patient Information and Consent.............................................................................22
8.2. Patient Withdrawal..................................................................................................23
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............23
8.4. Ethical Conduct of the Study ..................................................................................23
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS......................................23
9.1. Requirements...........................................................................................................23
9.2. Reporting Period .....................................................................................................25
9.3. Causality Assessment..............................................................................................25
9.4. Definitions of Safety Events ...................................................................................25
9.4.1. Adverse events............................................................................................25
9.4.2. Serious adverse events................................................................................25
9.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours ...........26
9.5. Single Reference Safety Document.........................................................................29
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........29
11. COMMUNICATION OF ISSUES ....................................................................................29
12. PUBLICATION OF STUDY RESULTS..........................................................................29

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1. LIST OF ABBREVIATIONS
Abbreviation
Definition
ADR
Adverse Drug Reaction
AE
Adverse Event
CGI-I
Clinical Global Impression-Improvement
CRF
Case Report Form
IEC
Independent Ethics Committee
IRB
Institutional Review Board
LSLV
Last Subject Last Visit
MDD
Major Depressive Disorder
MFDS
Ministry of Food and Drug Safety
PCD
Primary Outcome Completion Date
PMS
Post Marketing Surveillance
SAE
Serious Adverse Event
SRSD
Single Reference Safety Document

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2. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Title
Affiliation
Address
, MD
Non-Interventional 
Study Lead
Pfizer 
Pharmaceuticals 
Korea Ltd.
Seoul, Korea, 
Republic of
PPD

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3. AMENDMENTS AND UPDATES
Amendment 
number
Date
Substantial or 
administrative 
amendment
Protocol 
section(s) 
changed
Summary of amendment(s)
Reason
Amendment 1
5Mar2015
Substantial
7.1.
7.3.3.1.
7.7.
Convert study design prospectively.
Add long-term use study.
Add separate analysis in special 
subject group.
following the guideline of post-
marketing surveillance
Amendment 2
11Nov2015
Substantial
1.
4.
6.
7.
8.
9.
Entire 
document
Add abbreviations.
Add milestones and modify planned 
dates.
Change MFDS Notification No.
Clarify descriptions for research 
methods, subject exclusion criteria, 
subject 
observation 
period, 
effectiveness and safety assessment 
and modify/add minor wording.
Modify minor wording.
Modify/add/delete some phrases 
following the Pfizer template and 
modify minor wording.
Change MFDS Notification No.
Modify terminology following the 
revised MFDS Notification.
Modifying contents requiring 
clear description among the 
protocol contents
Amendment 3
14Jan2016
Substantial
7.4.9.1.
Entire 
document
Modify the period within which
CGI-I evaluation is allowed in case 
of withdrawal from ‘within 6 weeks 
of the last administration’ to ‘within 
2 weeks of the last administration’.
Modify ‘28 calendar days’ to ‘28 
days’.
Reflecting MFDS 
recommendations
Amendment 4
29Mar2016
Administrative
7.4.10.2
9.1
9.4.3
Clarify the Korean translation of 
some phrases following the Pfizer 
template (English) regarding the 
safety 
reporting 
requirement 
(Korean version only).
Clarify the Korean translation of 
some phrases following the Pfizer 
template (English) regarding the 
safety 
reporting 
requirement 
(Korean version only).
Modify
or add some phrases 
following 
the 
Pfizer 
template
(English)
regarding
the 
safety 
reporting requirement.
Modify the Korean translation of 
some phrases following the Pfizer 
template (English) regarding the 
safety 
reporting 
requirement
(Korean version only).
Add the definition of ‘lack of 
efficacy’.
Keeping consistency with the 
Pfizer template (English) 
regarding the safety reporting 
requirement and clarifying the 
definition of ‘lack of efficacy’

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4. MILESTONES
Milestone
Planned date
Data collection start date
01 Dec 2015
Data collection end date
01 Dec 2018
MFDS interim report 1-1
05 Oct 2014
MFDS interim report 1-2
05 Apr 2015
MFDS interim report 2-1
05 Oct 2015
MFDS interim report 2-2
05 Apr 2016
MFDS interim report 3
05 Apr 2017
MFDS interim report 4
05 Apr 2018
MFDS interim report 5
05 Apr 2019
MFDS re-examination report
05 May 2020
5. RATIONALE AND BACKGROUND
The objective of the Re-examination system in Korea is to re-confirm the clinical usefulness 
of the product through collecting, reviewing, identifying and verifying the safety and 
effectiveness information about the product in general practice (usually for a period of 6 
years after the product is registered).  
PRISTIQ® (desvenlafaxine) is classified as a dual acting Serotonin and Norepinephrine 
Reuptake Inhibitor (SNRI). Desvenlafaxine extended-release tablets are indicated for the 
treatment of major depressive disorder (MDD) in adults and for the treatment of moderate to 
severe vasomotor symptoms (VMS) associated with menopause.
PRISTIQ® was approved by Ministry of Food and Drug Safety (MFDS) in Korea on 06 Feb
2014 for the treatment of Major Depressive Disorder (MDD).  This surveillance is conducted 
for preparing application material for re-examination under the Pharmaceutical Affairs Laws 
and its Enforcement Regulation, and observation of safety and effectiveness of PRISTIQ® in 
usual practice according to the Re-examination Guideline of New Drugs, Etc.
The re-exam period for PRISTIQ®is from 06 February 2014 to 05 February 2020, and the 
final study report should be submitted by 05 May 2020.  The analyzed study report based on 
collected data of 6 years must be submitted to MFDS within 3 months after the end of 
specified re-examination period (from the product approval date to 6 years afterwards).

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6. RESEARCH QUESTION AND OBJECTIVES
The objectives of this study are to determine any problems or questions associated with 
PRISTIQ® after marketing, with regard to the following clauses under conditions of general 
clinical practice, in compliance with the regulation “Re-examination Guideline of New Drugs, 
Etc” (Ministry of Food and Drug Safety Notification 2015-79, 2015.10.30, amended). 
(1) Serious adverse event/adverse drug reaction
(2) Unexpected adverse event/adverse drug reaction that has not been reflected in the 
approved drug label. 
(3) Known adverse drug reaction 
(4) Non-serious adverse drug reaction 
(5) Other safety and effectiveness information 
7. RESEARCH METHODS 
7.1. Study Design 
This study is open-label, non-comparative, observational, non-interventional, prospective and 
multi-center study in which subjects are administered PRISTIQ® as part of routine practice at 
Korean health care centers by accredited psychiatrists. The observation period for each 
subject is from initiating administration of PRISTIQ® until week 8. If administration is 
discontinued before week 8, observation should be done for at least 28 days from the last
administration day. There will be no visit or activity mandated by this study and routine 
observation will be done during the above-mentioned period.
7.2. Study Size
600 patients will be enrolled in approximately 20 study centers in this study based on the 
MFDS re-examination regulation (Section 7.3.3). Most of the study centers would be general 
hospitals or psychiatric hospitals which have the accredited psychiatrists eligible for 
conducting PMS study. 
Subjects will be enrolled by continuous registration method. It means that the physician 
should consecutively enroll all patients who are administered PRISTIQ® for the first time and 
satisfy the inclusion and exclusion criteria after contract is made and the study is initiated.  
7.3. Setting
7.3.1. Inclusion criteria
1) Adults 19 years of age or older, who have been administered at least one dose of 
PRISTIQ® for the treatment of Major depressive disorder (MDD).

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2) Patients who have been administered PRISTIQ® for the first time after signing the data 
privacy statement.
7.3.2. Exclusion criteria
Patients to whom PRISTIQ® is contraindicated as per the local labeling;
1)
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any 
excipients in the PRISTIQ® formulation.
2)
This drug must not be used in combination with a MAOI, or within at least 14 days of 
discontinuing treatment with a MAOI.
7.3.3. Duration of the study
According to MFDS re-examination regulation, the re-examination report based on collected 
data of 6 years must be submitted to MFDS within 3 months after the end of specified re-
examination period (from the product approval date to 6 years afterwards). The re-exam 
period is from 06 February 2014 to 05 February 2020, and the final study report should be 
submitted by 05 May 2020. 
The data collection period of this study is until the required subject number (600 patients) is 
collected. The observation period for each subject is from initiating administration of 
PRISTIQ® until week 8. If administration is discontinued before week 8, observation should 
be done for at least 28 days from the last administration day. All the data collected during the 
observation period should be recorded in the case report form (CRF). In case of an adverse 
event/safety event recognized after the observation period ends, it should be recorded in the 
CRF as specified in Section 9.
7.3.3.1. Long-term use study
As PRISTIQ® could be used in a long time considering its indication, data from the patients 
administered in a long time out of enrolled patients will be collected and analyzed separately. 
Safety and effectiveness data of at least 60 subjects who have been administered PRISTIQ®
over 6 months out of enrolled subjects will be collected.
7.3.4. Dosage and administration
The use and dosage recommendations for PRISTIQ® should take place on the basis of the 
approved local product document. If subjects have been administered PRISTIQ® off label, 
they should be excluded from the safety analysis set and analyzed separately.
Refer to the most updated local product document for the detailed information on 
prescription. 
7.4. Study Procedures
All patients who are eligible for this study will be enrolled and evaluated. 

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There will be no visit mandated, but at least once safety information should be followed up 
by visit, telephone, e-mail or fax etc. during the study. The investigator should record the 
following information on the patient’s CRF:
7.4.1. Information of institution
The following will be recorded in the CRF for each patient:

CRF number (Patient number): The investigator will sequentially assign each patient a 
patient identification number, which will be a 4-digit number.  It will be combined with 
code number of institution by sponsor.

Name of institution

Name of department

Name of investigator

Date of signing data privacy statement

Signature of investigator: Contracted investigator must sign after identifying the CRF. 
7.4.2. Patient information (Baseline)
The following will be recorded in the CRF for each patient:

Inclusion criteria: Subjects can be enrolled with satisfying all inclusion criteria.

Exclusion criteria: Subjects cannot be enrolled with meeting any of exclusion criteria.

Age

Sex

Pregnancy: If ‘yes’, then record the week of pregnancy.

Breast-feeding

Diagnosis

Diagnosis date

Severity of the disease 
7.4.3. Medical history
Select among ‘yes’ or ‘no’ for medical history of followings. Past or present disease 
(including hepatic and renal impairment) will be determined based on the first PRISTIQ®

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administration date.  Record adequate full name of the disease down as the Medical 
Terminology Dictionary indicates (written by Korean Medical Society).
7.4.3.1. Renal disorder / Hepatic disorder
If ‘yes’, record the name of the disease, severity and status.
7.4.3.2. Allergic history
If ‘yes’, record the allergen and status.
7.4.3.3. Other diseases / symptoms
If ‘yes’, record the name of the disease and status.
7.4.4. Recent past psychotropic medication
Select among ‘yes’ or ‘no’ for past psychotropic medications which were terminated within 
30 days before the first administration of PRISTIQ®. The following will be recorded in the 
CRF for each patient:

Name of medication

Route of administration

Treatment start date

Treatment stop date
7.4.5. Administration status for PRISTIQ®
Record the followings with regard to administration status for the study drug. If the posology 
is changed (including wash-out), please record in a separate row and the reason.

Treatment start date

Treatment stop date

Daily dosage and frequency

Reason for dose adjustment: Select one among ‘planned dose increase or decrease’, ‘cure
or improvement’, ‘occurrence of adverse event’, ‘withdrawal due to lack of efficacy’ or 
‘other’. If ‘other’, record the specific reason.
7.4.6. Concomitant medications
Record the medicated drug while PRISTIQ® is being administrated. First select either ‘yes’ 
or ‘no’ then record in more details if selected ‘yes’.

Name of medication (generic name)

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
Treatment start date

Treatment stop date

Ongoing: If the treatment is not terminated until the timing of CRF completion, check 
‘ongoing’.

Purpose of treatment: Select one among ‘treatment for major depressive disorder’, 
‘treatment for other diseases’, ‘treatment for an adverse event’, ‘prevention of drug side 
effect’, or ‘other’. If ‘other’, record the specific reason.
7.4.7. Blood Pressure
If the physician performed blood pressure check for diagnostics or monitoring in usual 
medical practice, check ‘done’ and record the results. If there is any clinically significant 
abnormal result in blood pressure during or after administration compared to one before 
administration, please check ‘yes’ and record the abnormality in “9. Safety evaluation” 
clause.

Date of blood pressure check (before / during / after)

Results (sBP  / dBP)
7.4.8. Clinical laboratory
If the physician performed laboratory test for diagnostics or monitoring in usual medical 
practice, check ‘done’ and record the results. If there are any clinically significant 
abnormality in laboratory test results during or after administration compared to one before 
administration, please check ‘yes’ and record the abnormality in “9.Safety evaluation” clause.

Laboratory test item

Normal range (unit)

Date of laboratory test

Test results (before / during / after)
7.4.9. Effectiveness Evaluation
7.4.9.1. CGI-I scale (Clinical Global Impression – Improvement scale)
Clinical effectiveness will be evaluated after 8 weeks treatment (within 2 weeks of the last 
administration) using CGI-I scale as follows. In case of long-term use study subject, the 
result will be also assessed after 6 months treatment of PRISTIQ® (within 2 weeks of the last 
administration). 

1. Very much improved

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
2. Much improved

3. Minimally improved

4. No change

5. Minimally worse

6. Much worse

7. Very much worse
7.4.9.2. Final effectiveness evaluation
Final effectiveness will be evaluated at completing the administration of PRISTIQ® or at 
around 8 weeks treatment if PRISTIQ® has been still administered. In case of long-term use 
study subject, the result will be assessed after 6 months treatment of PRISTIQ®. Final 
effectiveness will be evaluated as ‘improved’, ‘no change’, ‘worse’ or ‘unevaluable’ based 
on overall patient’s clinical response, CGI-I scale and investigator’s judgment. 

Improved: In the case of judgment that there is the improvement of symptoms related 
to MDD.

No change: In the case that there is no significant change compared to patient’s status 
before PRISTIQ® administration.

Worse: In the case that symptoms are getting worse compared to patient’s status 
before PRISTIQ® administration.

Unevaluable: In the case that the medical charts do not have adequate progress notes 
to make a judgment on clinical response.
7.4.10. Safety Evaluation
Safety will be assessed based on adverse events reported for all patients who received at least 
one dose of PRISTIQ® and completed safety follow-up. Any adverse events will be recorded 
in the CRF including the information of the specific conditions or events, duration of the 
event persisted, seriousness, severity, causal relationship to PRISTIQ®, actions taken, and 
outcome.
7.4.10.1. Definition of 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 adverse events include but are not limited to:  

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 adverse event are as follows: 

Test result is associated with accompanying symptoms, and/or

Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or

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
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 adverse event by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an adverse event.  Any abnormal test result that is determined to be an error does 
not require reporting as an adverse event.
7.4.10.2. Definition of serious adverse events (SAEs)
A serious adverse event 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 adverse events);

Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions);

Results in congenital anomaly/birth defect.

Is important medical event (if it is determined that the event may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in the 
definition above)
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 PV personnel.  Such cases are also considered for reporting as product defects, if 
appropriate.

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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)

Protocol-specified admission during clinical study (e.g., for a procedure required by the 
study protocol)
7.4.10.3. Adverse events data collection
The investigator collects data on safety events as specified in Section 9 including all adverse 
events that occur during the observation period regardless of causal relationship to PRISTIQ®.  
The information on adverse events should include the specific conditions or events, duration 
of the events (start date and stop date), seriousness (serious or non-serious), severity, causal 
relationship to PRISTIQ®, actions taken, and outcome.
Check either ‘yes’ or ‘no’ in adverse event occurrence section. If ‘yes’, record in detail.

Adverse event: Record the term of adverse event. If possible, specify diagnosis, not 
individual symptoms. 

Date of onset: Record the date of onset. 

Severity: Severity evaluation of adverse events must be done according to the following 
category.

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1. Mild- Not causing any significant problem to the subject; Continuous medication of 
study drug is possible without dose adjustment. 
2. Moderate- Cause a problem that does not interfere significantly with usual activities or 
the clinical status; Dose adjustment of study drug or other therapy is needed due to 
adverse event.
3. Severe- Cause a problem that interferes significantly with usual activities or the 
clinical status; Study drug should be stopped due to adverse event.
If the severity of an adverse event changed, the adverse event must be entered separately. 
Record stop date of previous severity and onset date of new severity – along with completion 
of all other items.
•
Action: Check all relevant actions.
1) PRISTIQ®: Check the appropriate number for the adjustment of PRISTIQ® resulted 
from the adverse event.
1. Withdrawn (temporarily or permanently, or delayed)
2. Dose reduced 
3. Dose increased 
4. Dose not changed 
5. Unknown  
6. Not applicable
2) Others: After the onset of adverse event, the investigator should indicate other actions 
taken and record in detail.
1. Treatment given (please specify in concomitant medication section)
2. Others (please specify)
3. No action taken
•
Seriousness: Check either ‘yes’ or ‘no’ for the question, ‘Is this case under the criteria of 
serious adverse event?’ If ‘yes’, record the appropriate number for the category of 
seriousness.
A serious adverse event is any untoward medical occurrence at any dose that:
T results in death;

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T is life-threatening;
T requires inpatient hospitalization or prolongation of hospitalization;
T results in persistent or significant disability/incapacity  (substantial disruption of 
the ability to conduct normal life functions);
T results in congenital anomaly/birth defect.
T Is important medical event (if it is determined that the event may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in 
the definition above)
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 subject 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.
Record the followings at the end of the study or after the resolution of adverse event.
•
Outcome: Select among ‘yes’, ‘unknown’, or ‘no-resolved’ as a reply to a question, ‘Is 
the adverse event still present?’ If ‘no-resolved’, record the resolved date.
•
Causality of adverse event to the study drug: The causal relationship of adverse event to 
the study drug must be allocated by the psychiatrist according to the following criteria.
(1) Certain
T It follows a reasonable time sequence from administration of the drug (before and 
after the study medication).
T It could not be explained by other drugs, chemical substance or accompanying 
diseases.
T It has clinically reasonable reaction on cessation of the drug.
T It has pharmacological or phenomenological reaction to re-administration of the 
drug, where necessary.

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(2) Probable/likely
T It follows a reasonable time sequence from administration of the drug (before and 
after the study medication).
T It could not be explained by other drugs, chemical substance or accompanying 
diseases.
T It has clinically reasonable reaction on cessation of the drug (No information on re-
administration).
(3) Possible
T It follows a reasonable time sequence from administration of the drug.
T It could also be explained by other drugs, chemical substance or accompanying 
diseases.
T It lacks information or has unclear information on discontinuation of the drug.
(4) Unlikely
T It is not likely to have a reasonable causal relationship from administration of the 
drug. Rather, it seems to be temporary.
T It could also be reasonably explained by other drugs, chemical substances or latent 
diseases.
* Other causality of adverse event: If the adverse event is not related to the study 
drug, psychiatrists should indicate the most appropriate cause from the followings 
and record in detail.
1. Disease under the study
2. Other disease (please specify)
3. Concomitant treatment –drug or non-drug (please specify)
4. Others (please specify)
(5) Conditional/unclassified
T It needs more data to make an appropriate assessment or its additional data are 
being reviewed.

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(6) Unaccessible/unclassifiable
T Lack of sufficient information or conflicting information hampers accurate 
causality assessment or supplementation or confirmation.
7.5. Data Sources
7.5.1. Case report forms
The investigator will review source documents and complete an electronic CRF for each 
included patient.  The completed original CRFs are the sole property of Pfizer and should not 
be made available in any form to the third parties, except for authorized representatives of 
Pfizer or appropriate regulatory authorities, without written permission from Pfizer.
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs, 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 is true.  Any 
corrections to entries made on the CRFs must be dated, initialed and explained (if necessary) 
and should not obscure the original entry.
In most cases, the source documents are the hospital’s or the physician’s patient chart.  In 
these cases data collected on the CRFs must match the data in those charts. 
7.5.2. Record retention
To enable evaluations and/or audits from regulatory authorities or Pfizer, the investigator
agrees to keep records, including the original signed data privacy statement, identity of all 
participating patients (sufficient information to link records, e.g., CRFs and hospital records), 
copies of all CRFs, SAE forms, source documents, and detailed records of treatment 
disposition, and adequate documentation of relevant correspondence (e.g., letters, meeting 
minutes, telephone calls reports). The records should be retained by the investigator
according to local regulations, or as specified in the Clinical Study Agreement, whichever is 
longer.
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (e.g., retirement, relocation), Pfizer should be prospectively notified. The 
study records must be transferred to a designee acceptable to Pfizer, such as another 
investigator, another institution, or to an independent third party arranged by Pfizer. The 
investigator must obtain Pfizer’s written permission before disposing of any records, even if 
retention requirements have been met.
7.6. Data Management 
CRF data collected by the investigator will be entered into the clinical database.  
Verifications will be performed after comparison of the double data entry.  All missing data 
or data to be checked will be reported on a query sheet for further verification at the study 
site.  Any data modification will be recorded. 

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AEs will be coded using World Health Organization - Adverse Reaction Terminology.  
Medical history will be coded using Classification of Korea national statistical office.
Concomitant drugs will be coded via www.kimsonline.co.kr provided by KIMS Co. Ltd.
Statistical analysis will be carried out with SAS software version 9.2 or a more recent version. 
7.7. Data Analysis 
The data collected in this study will be documented in a Statistical Analysis Plan, which will 
be maintained by the sponsor. This document may modify the plans outlined in the protocol; 
however, any major modifications of primary endpoint definitions or their analyses will be 
reflected in a protocol amendment.
No formal sample size calculations were performed for this study. Six hundred (600 patients) 
or more will be collected as per the requirement by MFDS. Safety summaries will be based 
on the safety analysis set defined as those patients who met inclusion / exclusion criteria and 
completed safety follow-up. Effectiveness summaries will be based on the effectiveness 
analysis set, defined as those patients who took at least 8 weeks of PRISTIQ® and completed 
effectiveness evaluation.
In addition, special subject groups -elderly group (more than or equal to 65 years old), 
hepatic disorder group, renal disorder group and pregnancy group- will be analyzed 
separately.
7.7.1. Safety analysis
- Count and frequency of occurrence of adverse event, serious adverse event, adverse drug 
reaction or unexpected adverse event by category.  
- Count and frequency of occurrence of adverse events by subject baseline factor and by 
treatment factor to determine factors affecting the safety. 
- If there is any particular pattern in abnormal findings (including clinical laboratory 
abnormalities) occurring during or after the treatment which were considered unrelated to 
PRISTIQ®, the count and frequency of the events will be tabulated and analyzed to determine 
the casual relationship to the relevant study drug. 
7.7.2. Effectiveness analysis
Effectiveness endpoints include following variables: CGI-I scale and final effectiveness 
evaluation result at the date of effectiveness evaluation. Descriptive statistics (cell counts and 
percents) will be used to summarize this variable within the effectiveness analysis set 
population; the CGI-I scale and final effectiveness evaluation will also be summarized within 
subgroups of the effectiveness analysis set formed by demographic and other baseline factors 
such as sex, age and diagnosis date of MDD, etc. Comparisons across subgroups may be 
conducted using chi-squared tests at the 0.05 level of significance.

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7.7.3. Statistical consideration
The significance of the difference between sub-categories with regard to safety and 
effectiveness will be statistically analyzed using χ2 test (p≤0.05), etc. The frequency of 
occurrence of each adverse event will be presented with its 95% confidence interval.
To determine factors affecting the safety, the count and frequency of occurrence of all 
adverse events will be tabulated by type of the event and subject’s baseline factor (gender, 
age, presence of concurrent disease, etc.), and factors considered potentially affecting the 
safety will be analyzed using categorical data analysis method (Chi-square test, Fisher’s 
Exact test), etc. Serious adverse events, adverse drug reaction and unexpected adverse events, 
etc. will be also tabulated and summarized.
7.8. Quality Control
Quality assurance audits will be performed at study centers by the Pfizer’s own independent 
quality assurance group or by clinical research organization.  These audits will be conducted 
according to Pfizer’s procedures and the guidelines for Good Pharmacoepidemiology 
Practices (GPP) (see Section 8.4).
7.9. Limitations of the Research Methods
This is a non-interventional PMS study conducted in the Republic of Korea to satisfy the 
requirements of MFDS. The protocol is determined by regulation of MFDS and not the 
specific disease and drug characteristics.  The observational, non-controlled, and 
non-randomized design of this study has intrinsic limitations.
8. PROTECTION OF HUMAN SUBJECTS
8.1. Patient Information and Consent
All parties will ensure protection of patient personal data and will not include patient names 
on any sponsor forms, reports, publications, or in any other disclosures, except where 
required by laws.  In case of data transfer, Pfizer will maintain high standards of 
confidentiality and protection of patient personal data.
The data privacy statement must be in compliance with local regulatory requirements and 
legal requirements.
The data privacy statement used in this study, and any changes made during the course of the 
study, must be prospectively approved by both the Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) and Pfizer before use.
The investigator must ensure that each study patient, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the study and possible 
risks associated with participation.  The investigator, or a person designated by the 
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legally acceptable representative before any study-specific activity is performed.  The 
investigator will retain the original of each patient's signed data privacy statement.
8.2. Patient Withdrawal
Patients may withdraw from the study at any time at their own or their legally acceptable 
representative’s request, or they may be withdrawn at any time at the discretion of the 
investigator or sponsor for safety, behavioral, or administrative reasons. In any circumstance, 
every effort should be made to document subject outcome, if possible. The investigator 
should inquire about the reason for withdrawal and follow-up with the subject regarding any 
unresolved adverse events.  
If the patient withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected. The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
The study protocol will be submitted to MFDS prior to the study. The ethical consideration 
on this study will be evaluated by IRB/IEC in each clinical site prior to the study if the site 
has an approval process for this PMS study according to the local standard operation 
procedure of the site. 
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, and other relevant documents, if applicable, from the IRB/IEC.  All 
correspondence with the IRB/IEC should be retained in the Investigator File.  Copies of 
IRB/IEC approvals should be forwarded to Pfizer or its designee. 
8.4. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value and rigor and follow generally accepted research practices 
described in Guidelines for GPP issued by the International Society for 
Pharmacoepidemiology (ISPE), Good Epidemiological Practice (GEP) guidelines issued by 
the International Epidemiological Association (IEA), Pharmaceutical Research and 
Manufacturers Association (PhRMA) guidelines, and Korea PMS regulations and/or 
guidelines.
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS 
9.1. 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) 

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scenarios involving drug exposure, including exposure during pregnancy, exposure during 
breast feeding, medication error, overdose, misuse, extravasation, 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)
For each AE, the investigator must pursue and obtain information adequate both to determine 
the outcome of the adverse event and to assess whether it meets the criteria for classification 
as a SAE (see 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 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 adverse event 
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 
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9.2. Reporting Period 
For each patient, the safety event reporting period begins at the time of the patient’s first dose 
of PRISTIQ ®, and lasts through the end of the observation period of the study, which must 
include at least 28 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 days following the end of observation.
Most often, the date of data privacy statement is the same as the date of enrollment. In some 
situations, there may be a lag between the dates of data privacy statement and enrollment.  In 
these instances, if a patient provides data privacy statement but is never enrolled in the study 
(e.g., patient changes his/her mind about participation), the reporting period ends on the date 
of the decision to not enroll the patient.
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 PRISTIQ ®, 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 adverse event.  For AEs with a causal relationship to PRISTIQ ®, 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 PRISTIQ ® caused or contributed to an adverse event. If the 
investigator’s final determination of causality is “unknown” and s/he cannot determine 
whether PRISTIQ ® 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 
PRISTIQ ® did not cause the event, this should be clearly documented on the CRF and the 
NIS AEM Report Form. 
9.4. Definitions of Safety Events
9.4.1. Adverse events
Refer to the ‘7.4.10.1. Definition of adverse events’ clause.
9.4.2. Serious adverse events
Refer to the ‘7.4.10.2. Definition of serious adverse events (SAEs)’ clause.

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9.4.3. 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.
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) PRISTIQ®, or the female becomes, or is found to be, 
pregnant after discontinuing and/or being exposed to PRISTIQ® (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 
PRISTIQ® 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 exposures 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.
If a study participant or study participant’s partner becomes, or is found to be, pregnant 
during the study participant’s treatment with PRISTIQ®, this information must be submitted 
to Pfizer, irrespective of whether an adverse event has occurred using the NIS AEM Report 
Form and the EDP Supplemental Form. 
In addition, the information regarding environmental exposure to PRISTIQ® in a pregnant 
woman (e.g., a subject 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 be specified and, if clinically possible, the structural integrity of the 

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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:

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);

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
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
Lack of efficacy is defined as the failure of expected pharmacologic action or therapeutic 
benefit.
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.
Based on the “Safety Information Management Regulations for Drugs, Etc.”, the staff in 
charge of safety information at Pfizer Korea reports to the Director of Korea Institute of Drug 
Safety and Risk Management via website, telephone, fax, mail or in the form of electronic 
document using Appendix Form no. 1 in the Safety Information Management Regulations for 
Drugs, Etc. (MFDS Notification) within 15 days of awareness or being notified of the serious 
adverse event/adverse drug reaction in accordance with Article 5 Paragraph 4 of the Re-
examination Guideline of New Drugs, Etc (MFDS Notification no. 2015-79). Therefore, in 
case of a serious adverse event/adverse drug reaction, the investigator immediately notifies 
the staff in charge of safety information at Pfizer Korea. The investigator completes the

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‘Non-Interventional Study Adverse Event Report Form’ and must fax it within 24 hours of 
awareness of the applicable serious adverse event/adverse drug reaction.
9.5. Single Reference Safety Document
The local product document will serve as the SRSD during the course of the study, which 
will be used by Pfizer to assess any safety events reported to Pfizer Safety by the investigator 
during the course of this study. 
The SRSD should be used by the investigator for prescribing purposes and guidance.
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
For the first 2 years, 6-month reports will be submitted to MFDS (i.e., reports 1-1, 1-2, 2-1, 
and 2-2).  Thereafter, data collected in the 3rd, 4th, and 5th year will be reported to MFDS 
annually.  Final study report (i.e., re-examination report) will be submitted to MFDS in the 
6th year to include all data collected during the whole study period (see Section 4). 
11. COMMUNICATION OF ISSUES
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.  
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 NIS protocol that the investigator becomes aware of.
12. PUBLICATION OF STUDY RESULTS
Pfizer fulfils its commitment to publicly disclose study results through posting the results of 
this study on www.clinicaltrials.gov. Pfizer posts the results of all studies that is has 
registered on ClinicalTrials.gov regardless of the reason for registration.
The results are posted in a tabular format called Basic Results.

Basic Results are due within one anniversary year of the PCD and/or LSLV.

When PCD and LSLV are not the same date, Basic Results are posted one 
anniversary year from the PCD and the record is updated one anniversary year from 
the LSLV. The PCD cannot occur after the LSLV.