DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
Conditions: Neuralgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Lyrica® Capsule
Drug Use Investigation
Protocol
Pfizer Japan Inc.
Date prepared: April 8, 2013 (Version 2)
Protocol ID: A0081261
For Use in 
Application for 
Reexamination
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Introduction
Pregabalin, an active ingredient of Lyrica Capsule (hereinafter called “the product”), is one of the 
derivatives of γ-aminobutyric acid (GABA) developed at Northwestern University, USA.
In the excessively stimulated excitable nervous system, pregabalin binds with high affinity to α2δ 
protein (an auxiliary subunit of voltage-gated calcium channels), which supposedly reduces
calcium inflow into presynaptic nerve terminals and suppresses the synaptic release of excitatory 
neurotransmitters, consequently leading to manifestation of analgesic activity.
As of February 2012, the product has been approved for indications of neuropathic pain (peripheral 
neuropathic pain and central neuropathic pain) and the like in 120 countries of the world, including 
the US, European Union countries, Australia and Canada. In Japan, the product has been
approved for indications of peripheral neuropathic pain in October 2010, pain associated with 
fibromyalgia in June 2012, and neuropathic pain in February 2013.
The drug use investigation on Lyrica Capsule (hereinafter called “the survey”) will be undertaken to 
collect or check information about the incidence of each type of disorder arising from adverse 
reactions to the product and the information on quality, efficacy and safety of the product in routine
clinical use. The information collected through the survey will be supplied as the information on 
proper use of the product to medical facilities and used to prepare the application materials for 
reexamination of the product. To this end, the survey needs to be carried out in compliance with
the Good Post-marketing Surveillance Practice (Ministry of Health, Labour and Welfare [MHLW]
Ordinance No. 171, dated December 20, 2004). The case data collected through this survey will be 
reported to the MHLW pursuant to the Pharmaceutical and Medical Device Act. If applicable, the 
data including names of drugs, adverse reactions, gender and age by decade may be disclosed as 
a listing of patients in the “Pharmaceuticals and Medical Devices Safety Information” and 
“Pharmaceuticals and Medical Devices Information Website (http://www.info.pmda.go.jp)” which 
are issued and managed, respectively, by the MHLW. The collected case data may be also
disclosed if the MHLW is requested to disclose them pursuant to the “Act on Access to Information 
Held by Administrative Organs” (Act No. 42, dated May 14, 1999). In any of the above cases, the 
report does not cover the name of the physicians, facilities or the like involved, and these pieces of 
information will never be published or disclosed.
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1
Objectives
The objective of this survey is to evaluate the safety and efficacy of the product in routine
clinical practice. In addition, efforts will be made to collect information on the incidence of 
previously known and unknown adverse reactions that will occur under actual use conditions
during the survey period. At the same time, the necessity of conducting a special 
investigation or a post-marketing clinical study will be evaluated.
The following events will be evaluated as major investigation items;

Peripheral edema and edema-related events*

Dizziness, somnolence, loss of consciousness, syncope and potential for accidental 
injury

Vision-related events
*: Adverse events of the cardiovascular and respiratory systems will be also checked.
2
Study population
The survey covers the patients satisfying all of the following requirements:

Patients not participating in any other survey or study of the product

Patients having never used the product before the survey
The indications, dosage and administration of the product are specified below:
Indications: Neuropathic pain*, pain associated with fibromyalgia**
[Neuropathic pain]
Dosage and Administration: The usual starting dose in adults is 150 mg/day of 
pregabalin orally administered in 2 divided doses, 
which may be gradually increased to 300 mg/day over
one week or longer. The dose may be adjusted 
depending on age and symptoms as appropriate, 
provided the daily dose may not exceed 600 mg and 
the product should be orally administered in 2 divided 
doses regardless of the daily dose.
The latest version of the package insert should be 
referred to when the product is prescribed.
*
Neuropathic pain to be enrolled in April 2013 and thereafter will cover peripheral 
neuropathic pain including trigeminal neuralgia, peripheral entrapment neuropathy, 
iatrogenic neuropathy, neuropathy due to tumor-induced nerve compression or infiltration, 
posttraumatic pain, and chronic cauda equina syndrome, as well as central neuropathic 
pain.
**
The survey does not cover pain associated with fibromyalgia.
3
Target sample size
The target sample size is 3400 patients with neuropathic pain in total, including 3000 patients 
with peripheral neuropathic pain (1000 patients with post herpetic neuralgia, if possible, and 
2000 patients with peripheral neuropathic pain of the types other than post herpetic 
neuralgia), and 400 patients with central neuropathic pain (300 patients with post-stroke pain, 
if possible, and other patients with pain following traumatic spinal cord injury and pain due to 
Parkinson’s disease). For peripheral neuropathic pain, approximately 100 each of patients 
should be accumulated, if possible, for trigeminal neuralgia, peripheral entrapment 
neuropathy, iatrogenic neuropathy, neuropathy due to tumor-induced nerve compression or 
infiltration, posttraumatic pain, and chronic cauda equina syndrome.
[Rationale]
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The target sample size of 3400 patients with neuropathic pain is expected to have a 97% 
probability to detect adverse reactions occurring at the incidence of 0.1% or higher in at least 
1 patient. Of the adverse reactions included in the major investigation items, vision-related
events are anticipated to develop at the lowest incidence during the survey. In clinical studies 
of the product conducted in Japan and overseas, the lower bound of the 95% confidence 
interval for the incidence of this adverse reaction was 6.70% (incidence 7.40%, 380/5134 
patients). If this adverse reaction develops at the same incidence as in these clinical studies, 
this reaction is expected to occur in 227 or more of 3400 patients. Since the safety and 
efficacy of the product should be evaluated in patients with each type of neuropathic pain, 
enrollment of the following number of patients will be ensured; approximately 100 patients 
each, if possible, for trigeminal neuralgia, peripheral entrapment neuropathy, iatrogenic 
neuropathy, neuropathy due to tumor-induced nerve compression or infiltration, posttraumatic 
pain, and chronic cauda equina syndrome, approximately 300 patients for post-stroke pain, 
and a certain number of patients for pain following traumatic spinal cord injury and pain due to 
Parkinson’s disease.
This sample size will also allow for adequate evaluation of the characteristics of other adverse 
reactions included in the major investigation items. The characteristics to be evaluated
include time of onset and duration of adverse reactions, and these were also investigated in 
the clinical studies.
4
Planned survey period
The survey period and the period for registration into the survey are specified below:
Survey period*
: January 2011 to April 2017
Registration period
: January 2011 to January 2017
* 
A contract will be concluded on or after the first day of the survey period, and 
registration of patients will be subsequently started. Observation of all registered 
patients will be completed by the last day of the contract period.
5
Survey procedures
5.1 Survey method
The survey will be conducted with the central registration system. Patient registration will be
continued until the number of registered patients reaches the target number.
5.2 Data collection method
During this survey, an Internet-based electronic data collection system for post-marketing 
surveillance will be used for patient registration, survey data entry and data confirmation. 
PostMaNet of Fujitsu FIP Corporation (hereinafter called “the system”) will be utilized for this 
survey. Security during data transmission will be ensured by authenticating each investigator 
with individual user ID and password and using the latest protocol for SSL enciphered 
communication. Detailed procedure and methods for data entry, correction and confirmation 
are separately specified in the data entry sample etc.
5.3 Patient registration
After the user ID and password are issued to each investigator, the investigator will enter the 
following basic information on the patient registration screen: name initials of the patient (as 
needed), ID code, gender, birth date, starting date for treatment with the product and 
eligibility to the survey. Considering that the incidence of adverse events (peripheral edema, 
dizziness, etc.) was highest during the early stage of treatment with the product in phase 3 
studies conducted in Japan, registration of patients should be done within 7 days after the 
start of treatment with the product, as a rule (within 14 days at latest) to enable appropriate 
collection of information on these adverse events.
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5.4 Observation period
The observation period will start on the first day of treatment with the product (Day 1) and last 
until Week 13 (Day 91). However, in cases where treatment has been completed or discontinued 
before Week 13, observation will be continued until completion (discontinuation) of treatment, 
and follow-up will be made for one week (7 days) after completion (discontinuation) of treatment.
During this survey, safety will be evaluated on the day of the first visit after the end of the 
observation period (including the last day of the observation period), as a rule. In cases where 
treatment has been completed or discontinued, safety will be evaluated until the day of the first 
visit following 7-day period after the completion (discontinuation) of treatment, and safety 
information will be collected for this period.
Supplementary note: Completion of treatment means cases where further treatment with the 
product is judged unnecessary because of achievement of the 
purpose of treatment set at the start of treatment (e.g., cure of target 
diseases).
5.5 Precautions in data entry, correction and confirmation
(1) Data entry
The investigator should check each survey item and enter and transmit the data into the 
system, on the basis of the records of healthcare (medical records, test reports, etc.). 
Data entry sample etc. should be referred to for detailed procedure.
(2) Data correction
If Pfizer Japan Inc. (hereinafter called “the sponsor”) places inquiry about the entered 
information, the investigator should check the above-mentioned healthcare records 
again and, as needed, correct the once entered data and transmit the corrected data. 
Data entry sample etc. should be referred to for detailed procedure.
(3) Data confirmation
Upon completion of entry and correction of all survey data, the investigator should
check the survey form and attach his/her electronic signature to it. Data entry sample 
etc. should be referred to for detailed procedure.
6
Items and schedule of survey
The investigator will conduct the survey in accordance with the observation schedule given
below. After conclusion of the contract on the survey, the investigator will register eligible 
patients. Then, the investigator will check the data on each registered patient (including the 
data on background variables at the start of treatment) and fill in the survey form for each 
patient.
First day of 
treatment
Week 4
Week 8
Week 13
Patient A
Patient B
Completion/
discontinuation
Treatment is 
continued.
[Treatment is continued as of 
Week 13]
→Without follow-up period
[Treatment is
completed/discontinued at Week 8]
Follow-up is made for one 
week (7 days) after 
completion/discontinuation.
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Observation schedule
Registration 
form
Survey form
Time
Survey items
At 
registration
*1
Observation period
Start of 
treatment
Week 
4
Week 13
(or completion/
discontinuation)
7 days after 
completion/
discontinuation*4
Identifiable 
patient 
information
ID code


Name initials (not indispensable)


Gender


Birth date


Eligibility


Background 
variables
First day of treatment with the product


Target Disease 


Height/body weight *2

Hospitalization status 
(inpatient/outpatient)

Presence/absence of hepatic/renal 
dysfunction

Creatinine clearance

With or without hemodialysis

Presence/absence of ocular disease 
history/complications

Disease history

History of previous treatment drugs for 
the target disease *3

Pregnancy status (females only)

Records of treatment with the product
Concomitant therapy (drug therapy/non-drug therapy)
Tests (clinical findings/laboratory test)
(1) Body weight



(2)
Clinical 
findings
1. [Presence/absence 
of 
peripheral 
edema 
or 
edema 
in 
general], 
[Presence/absence 
of 
dizziness, 
somnolence, loss of consciousness, 
syncope or potential for accidental 
injury], 
[Presence/absence 
of 
ophthalmological 
abnormalities],
[Presence/absence 
of 
suicidal
ideation
(including suicide
attempt
and suicide after start of treatment)], 
[Presence/absence 
of 
pathologic 
changes in appetite and activity]


2. [Presence/absence 
of 
withdrawal
symptom/rebound phenomenon]

(3) Presence/absence of hyperalgesia


(4) Laboratory test
Clinical 
evaluation
(1) Patient-rated pain score
(2) Patient-rated sleep disorder score



(3) Patient’s impression (PGIC)
(4) Physician’s impression (CGIC)

Patient summary

Efficacy evaluation

Adverse events
Data to be entered; Data to be reflected
1) 
Entry at the time of patient registration. These pieces of information related to patient registration will be transmitted within 7 days 
after the start of treatment, as a rule, and within 14 days at the latest.
2) 
Body weight at the start of treatment will be entered in the field of “Body weight” in Tests (clinical findings/laboratory test).
3) 
The drugs previously used for the treatment of the target disease during the period from 14 days to 1 day before the start of 
treatment with the product will be entered.
4)
In cases where treatment has been completed (discontinued) before the end of the observation period, follow-up is made for one 
week (7 days) after completion (discontinuation) of treatment.
6.1 Background variables
(1) The information at the start of treatment will be entered in the patient registration form.
[1] ID code
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[2] Name initials (as needed)
[3] Gender
[4] Birth date
[5] First day of treatment with the product
[6] Eligibility
[7] Target disease
The relevant disease will be selected from the diseases listed below.
Post
herpetic neuralgia, painful diabetic neuropathy, other types of peripheral 
neuropathic pain, various types of central neuropathic pain, others
Table
Common disorders included in neuropathic pain 
[Classification by the site of nerve injury]
(Source: Reference 1)
Neuropathic pain
Peripheral neuropathic pain
Central neuropathic pain

Post herpetic neuralgia

Painful diabetic neuropathy

Complex regional pain syndrome

Chemotherapy-induced neuropathy

HIV-induced sensory neuropathy

Phantom pain*

Trigeminal neuralgia

Acute/chronic 
inflammatory 
demyelinating 
polyradiculoneuropathy

Alcoholic neuropathy

Peripheral entrapment neuropathy (carpal tunnel 
syndrome etc.)

Iatrogenic neuropathy
(post-mastectomy pain, post-thoracotomy pain, etc.)

Idiopathic sensory neuropathy

Neuropathy due to tumor-induced nerve compression 
or infiltration

Neuropathy due to malnutrition

Post-radiation plexopathy

Radiculopathy

Poisoning neuropathy

Post-traumatic pain

Traumatic avulsion injury of the brachial plexus*

Glossopharyngeal neuralgia

Autoimmune neuropathy

Chronic cauda equina syndrome*

Post-stroke pain

Pain following traumatic spinal cord injury

Pain due to multiple sclerosis

Compressive myelopathy due to spinal canal 
stenosis

Pain due to Parkinson’s disease

HIV-induced myelopathy

Post-ischemic myelopathy

Post-radiation 
myelopathy/post-radiation 
encephalopathy

Syringomyelia/syringobulbia
* May be viewed as both peripheral neuropathic pain and central neuropathic pain.
(2) The following information at the start of treatment will be entered in the survey form.
[1] Height
[2] Body weight (information at the start of treatment will be entered in (1) “Body 
weight” in Section 6.4 Tests.)
[3] Hospitalization status (inpatient/outpatient)
[4] Target disease (name of the disease or diagnosis requiring use of the product), 
major site affected, duration of sickness, underlying disease and its duration
[5] Presence/absence and severity of hepatic dysfunction and renal dysfunction
Supplementary note: Hepatic/renal dysfunction means events requiring clinical 
attention and follow-up, rather than temporary abnormalities in 
laboratory data. 
[6] Creatinine clearance
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[7] Whether the patient is on hemodialysis or not
[8] Presence/absence of ocular disease history/complications
[9] Disease history

Name of disease or syndrome

Whether the disease is a past one or is present now.
Supplementary note: The name of chronic disease (including allergy), disease 
requiring treatment, disease or disorder requiring or causing 
surgery, hospitalization or sequelae, and other possibly 
problematic disease or syndrome will be recorded. The disease 
or syndrome seen before the start of treatment with the product 
is counted as “disease history” and the disease or syndrome 
present at the start of treatment is counted as “complication.”
[10] History of previous treatment drugs for the target disease
(Drugs used during the period from 14 days to 1 day before the start of treatment with 
the product)

Name of drug (brand name)

Route of administration

Daily dose

Number of doses per day

Dosing period

Reasons for discontinuation
(3) The following information for the period until the day of safety evaluation will be entered.
[1] Pregnancy status and date of delivery/planned date of delivery (females only)
6.2 Records of treatment with the product
The following information about the product use until the day of safety evaluation will be
entered:
[1] Daily dose
[2] Number of doses per day
[3] Dosing regimen (morning/noon/evening/bedtime, before meal/after meal/others)
[4] Dosing period
In cases receiving hemodialysis, the following information will be also entered:
[5] Frequency of dialysis
[6] Duration of each session of dialysis
[7] Supplemental dose after dialysis
6.3 Concomitant therapy
(1) Drug therapy
The following information will be entered about all drugs used by the day of safety 
evaluation. If any adverse event occurs, information will be also entered about the 
concomitant drugs used during the period from the first day of treatment to the onset of the 
adverse event. Medications used for treatment of the adverse event should be also 
recorded.
[1] Name of drug (brand name)
[2] Route of administration
[3] Daily dose
[4] Number of doses per day
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[5] Dosing period
[6] Reasons for the use of drugs
(2) Non-drug therapy
The following information will be entered about the non-drug therapies used by the day of 
safety evaluation. If any adverse event occurs, information will be also entered about the 
non-drug therapies used during the period from the first day of treatment to the onset of 
the adverse event. The non-drug therapies used for treatment of the adverse event should 
be also recorded.
[1] Name of therapy
[2] Period of use
[3] Reason for use
6.4 Tests (clinical findings/laboratory test)
(1) Body weight
The following information will be entered. The body weight will be measured before the start of 
treatment with the product (including the first day of treatment), at Week 4 and Week 13, and 
by the day of safety evaluation. If the investigator considers that the change in body weight
from the pre-treatment level is abnormal, it will be reported as an adverse event.
[1] Date of evaluation
[2] Results
(2) Clinical findings
The following information will be entered about the clinical findings before the start of 
treatment (including the first day of treatment) and during the period from the start of 
treatment to the day of safety evaluation. In cases where treatment has been completed or 
discontinued before Week 13, the data at the time of completion (discontinuation) of treatment 
will be entered. If the investigator considers that the change in any of the clinical findings from 
the pre-treatment status is abnormal, it will be reported as an adverse event.
(2)-1 Information before the start of treatment (including the first day of treatment) and during 
the period from the start of treatment to the day of safety evaluation
[Presence/absence of peripheral edema or edema in general]*, [Presence/absence of 
dizziness, somnolence, loss of consciousness, syncope and potential for accidental injury], 
[Presence/absence of ophthalmological abnormalities], [Presence/absence of suicidal 
ideation (including suicide attempt and suicide after start of treatment), [Presence/absence of 
pathologic changes in appetite and activity]
Supplementary note*: In cases where peripheral edema or edema in general is found, 
adverse events of the cardiovascular and respiratory systems also 
need to be checked. If any clinically significant change from the 
pre-treatment condition is found, it should be entered in detail in the 
field for adverse events.
(2)-2 Information in cases of completed (discontinued) treatment with the product (information 
on the day of safety evaluation following 7-day period after the day of discontinuation 
[including Day 7 of this period])
[Presence/absence of withdrawal symptom/rebound phenomenon]
(3) Presence/absence of hyperalgesia
Information will be entered about the presence/absence of hyperalgesia before the start of 
treatment (including the first day of treatment) and at Week 13. In cases where treatment has 
been completed or discontinued before Week 13, the data at the time of completion 
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(discontinuation) of treatment will be entered. If the investigator considers that the change in
the condition of hyperalgesia from the pre-treatment status is abnormal, it will be reported as 
an adverse event.
(4) Laboratory test
The data on the following laboratory parameters tested before the start of treatment with the 
product (including the first day of treatment) and during the period from the start of treatment 
to the day of safety evaluation will be entered. If the investigator considers that the change in 
any of the following parameters from the pre-treatment level is abnormal, it will be reported as 
an adverse event.
(Serum creatinine, serum amylase, serum total thyroxine [T4], thyroid stimulating hormone 
[TSH], blood glucose [fasting level], hemoglobin A1c [HbA1c])
[1] Date of measurement
[2] Results
6.5 Clinical evaluation
(1) Patient-rated pain score
Before the start of treatment (including the first day of treatment) and at Week 4 and Week 13, 
the pain experienced during the past 24 hours will be rated at the time of getting up in the 
morning on a 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). 
In cases where treatment has been completed or discontinued before Week 13, the data at 
the time of completion (discontinuation) of treatment will be entered.
(2) Patient-rated sleep disorder score
Before the start of treatment (including the first day of treatment) and at Week 4 and Week 13, 
the sleep disorder (inability to sleep because of pain) experienced during the past 24 hours 
will be rated at the time of getting up in the morning on a 11-grade scale, ranging from 0 (no 
disturbance of sleep) to 10 (totally unable to sleep because of pain)]. In cases where 
treatment has been completed or discontinued before Week 13, the data at the time of 
completion (discontinuation) of treatment will be entered.
(3) Patient’s impression (Patient Global Impression of Change [PGIC])
The patient’s impression about the condition at Week 13, as compared to the condition before 
the start of treatment (including the first day of treatment), will be rated on a 7-grade scale, 
ranging from 1 (markedly improved) to 7 (markedly worsened). In cases where treatment has 
been completed or discontinued before Week 13, the data at the time of completion 
(discontinuation) of treatment will be entered.
1.
Markedly improved
2.
Improved
3.
Slightly improved
4.
Unchanged
5.
Slightly worsened
6.
Worsened
7.
Markedly worsened
(4) Physician’s impression (Clinical Global Impression of Change [CGIC])
The physician’s impression about the condition at Week 13, as compared to the condition 
before the start of treatment (including the first day of treatment), will be rated on a 7-grade 
scale, ranging from 1 (markedly improved) to 7 (markedly worsened). In cases where 
treatment has been completed or discontinued before Week 13, the data at the time of 
completion (discontinuation) of treatment will be entered.
1. Markedly improved
2.
Improved
3.
Slightly improved
4.
Unchanged
5.
Slightly worsened
6.
Worsened
7.
Markedly worsened
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6.6 Patient summary
The appropriateness of continuation of treatment with the product will be checked on the day of 
safety evaluation. In cases where continuation of treatment with the product is not possible, one 
major reason should be selected from the alternatives given below. If adverse events, 
abnormalities in laboratory parameters or the death of patient is selected as a major reason, the 
relevant data should be entered in the “adverse event” field.
[1] Insufficient clinical efficacy
[2] Recovery (effective)
[3] Adverse events
[4] Abnormalities in laboratory parameters
[5] Death of patient
[6] Lost to follow-up
[7] Others
In cases where no revisit has been made after the start of treatment, it should be entered in the
“Confirmation of revisit after the start of treatment” field.
6.7 Efficacy evaluation
The efficacy of the product at Week 13 as compared to the condition before the start of treatment 
(including the first day of treatment) will be evaluated in the following way, and the judgment will 
be entered. In cases where treatment has been completed or discontinued before Week 13, the 
data at the time of completion (discontinuation) of treatment will be entered.
[1] Date of efficacy evaluation
[2] Clinical efficacy

Effective

Ineffective

Impossible to judge (enter the reason)
Items of evaluation
The reason for judging “effective” or “ineffective” should be entered (multiple choices 
allowed).

Changes in clinical symptoms

Others
6.8 Adverse events
For evaluation of safety, the incidence of adverse events following the start of treatment with the 
product will be checked, and the following information will be entered. If any adverse event
occurs, the investigator should take appropriate measures and immediately report it to the 
sponsor. When the causal relationship between the event and the product cannot be ruled out,
observe the course of event or its sequela until they disappear or become stabilized at the level 
acceptable for the investigator and the sponsor.
A detailed investigation will be separately carried out if patients have intrauterine exposure or 
develop serious adverse reactions, adverse reactions not listed in the package insert and the like
and the sponsor deems it necessary.
[1] Day of safety evaluation (as a rule, day of last visit within 29 days after the start of 
treatment)
[2] Presence/absence of adverse events
[3] Name of adverse event
[4] Date of onset
[5] Measures taken
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[6] Seriousness
[7] Outcome
[8] Causal relationship to the product
[The following information should be entered if the adverse event is associated with
abnormal changes in test data such as laboratory tests.]
[1] Name of test
[2] Reference value at the facility
[3] Unit
[4] Date of measurement
[5] Results
Supplementary note: Adverse events mean all events unfavorable for the patient, arising 
after the start of treatment with the product, regardless of 
presence/absence of causal relationship to the product (including 
clinically significant abnormal changes in laboratory parameters). 
Serious adverse events mean death, life-threatening events, and 
events possibly causing hospitalization, extension of hospital stay 
period, permanent or marked disorders/disabilities, congenital 
anomalies/defects or other medically significant events/disorders.
6.9 Major investigation items
The following events should be evaluated as major investigation items in this survey.
[1] Peripheral edema and edema-related events
Information will be collected about the presence/absence of events related to 
peripheral edema and the course of patients before and after the onset of events. 
The situations on development of these events will be analyzed by means of factor 
analysis, including analysis of the site affected, dose of the product, concomitant 
therapy, background variables, etc. The package insert gives precautions on 
congestive heart failure in patients presenting symptoms related to edema. In 30 
overseas placebo-controlled studies, the incidence of hypertension and dyspnea 
was higher in the patients developing peripheral edema than in patients free of 
peripheral edema, although the incidence of the other events did not differ markedly 
between these two groups. In view of these facts, information on cardiac function 
and the incidence of adverse events of the respiratory system will be also collected.
[2] Dizziness, somnolence, loss of consciousness, syncope and potential for accidental 
injury
Information will be collected about the presence/absence of events related to 
dizziness, somnolence, loss of consciousness, syncope and potential for accidental 
injury and the course of patient’s condition before and after the onset of events. The 
situations on development of these events will be analyzed by factor analysis, 
including analysis of the dose of the product, concomitant therapy, background 
variables and so on.
[3] Vision-related events
Information will be collected about the presence/absence of events related to the 
eyes and the course of patient’s condition before and after the onset of events. The 
situations on development of the events will be analyzed by factor analysis, including 
analysis of the dose of the product, concomitant therapy, background variables and 
so on.
Patients developing adverse events included in the major investigation items will be 
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separately investigated in detail if the sponsor deems it necessary.
7
Analysis plan
7.1 Analysis set
As a rule, safety analysis set will include patients who satisfy the eligibility criteria and have been 
confirmed to have taken the product at least once. As a rule, efficacy analysis set will include 
patients who are evaluable for efficacy in accordance with the separately set analysis plan (i.e., 
patients in whom efficacy was considered to be appropriately evaluated).
7.2 Methods of analysis
7.2.1 Safety analysis
In the safety analysis set, the status of onset of adverse reactions and incidence of adverse 
reactions (percentage of patients developing adverse events for which the causal relationship 
with the product cannot be ruled out) will be set as primary analysis items. The factors 
affecting the incidence of adverse reactions will be also analyzed, for example, the incidence 
of adverse events will be summarized for each of the factors including background variable.
7.2.2 Efficacy analysis
In the efficacy analysis set, the response rate will be set as a primary analysis item. As needed, 
explorative analysis of factors affecting the efficacy will be also carried out.
7.3 Time of analysis
7.3.1 Periodical safety report
Interim analysis will be conducted at intervals of 6 months during the first two years after 
approval of the product and once a year during the subsequent reexamination period.
7.3.2 Submission of application for reexamination
Final analysis will be conducted upon completion of the reexamination period.
8
Publication of the results
Pfizer Japan Inc. will publish the results of one of the following surveys. As needed, the 
company will publish the results of survey at academic society meetings, in journals and so 
on for the purpose of supplying information for proper use of the product.

The survey registered in www.clinicaltrials.gov (ClinicalTrials.gov), regardless of the 
reason for registration

Other survey judged to have yielded scientifically or medically significant results
The timing for publication of the survey results will be determined based on whether or not 
the product has been approved in any country at the completion of the survey on the product.
The results of the survey on the product already approved in a given country should be
published within one year after fixation of the patient’s data collected during the last visit.
Only the published papers which can be accessed via the widely accepted and searchable 
databases on papers will be cited.
9
Contact information
9.1 Contact information for the contents of survey
Name
Post-Marketing Surveillance Division, Pfizer Japan Inc.
Address
Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589
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Fax
+81-3-5309-9186
E-mail
Lyrica_EDCMED@pfizer.com
9.2 Contact information for the system
Name
PostMaNet CSD, Fujitsu FIP Corporation
Address
2-20-5 Shimokodanaka, Nakahara-ku, Kawasaki City, Kanagawa Prefecture 
211-8520
Business 
hours
Monday through Friday, 9:00 a.m. to 9:00 p.m. (excluding national holidays)
Tel
+81-120-002-593
10
References

Attachment 1: Adverse event report

Reference 1: Hanaoka K et al., Journal of Pain Clinic 30(10):1395-1408, 2009 
[L20091007038]
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