SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
Conditions: Non-small Cell Lung Cancer
Sponsor: Pfizer

Special Investigation for 
XALKORI CAPSULES
- Survey for ALK fusion gene-positive non-small cell lung 
cancer -
Implementation Guideline
Pfizer Japan Inc.
    Date prepared: April 27, 2012 Ver.1
Protocol No: A8081031
For application for 
reexamination

                        Date prepared: April 27, 2012 Ver. 1
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            Protocol No. A8081031 
Introduction
Xalkori Capsule (generic name: crizotinib) (hereinafter referred to as “this drug”) is an 
ATP-competitive kinase inhibitor that selectively inhibits a receptor tyrosine kinase (RTK) of the 
anaplastic lymphoma kinase (ALK) and its carcinogens (ALK fusion proteins and specific ALK 
mutants). The marketing authorization of this drug was obtained on March 30, 2012 for the treatment 
of ALK fusion gene-positive, unresectable advanced and recurrent non-small cell lung cancer. 
A special investigation of Xalkori Capsule - Survey for ALK fusion gene-positive non-small cell lung
cancer – (hereinafter referred to as “this survey”) will be conducted to detect or verify the occurrence 
of diseases, etc. caused by adverse drug reactions of this drug by type and information on quality, 
efficacy and safety under the actual use of the drug in daily medical care. The information obtained in 
this survey will be used to provide the proper use information and prepare the data for application for 
reexamination. For this reason, this survey must be conducted in compliance with the “Ministerial 
Ordinance Related to Standards for the Implementation of Post-Marketing Survey and Studies on 
Drugs” (Ministerial Ordinance No. 171 of the Ministry of Health, Labour and Welfare dated December 
20, 2004). The patient data collected in this survey will be reported to the Ministry of Health, Labour 
and Welfare (MHLW) based on the Pharmaceutical Affairs Law. For the patients who developed 
adverse drug reactions, the information on drug names, adverse drug reactions, sex, age 
(generation), etc. may be published on the “Pharmaceuticals and Medical Devices Safety 
Information”
and 
“Website 
of 
the 
Pharmaceutical 
and 
Medical 
Devices 
Information 
(http://www.info.pmda.go.jp)” as a list of patients. In addition, the collected patient data will be 
disclosed if there is a disclosure request to the MHLW based on the “Act on Access to Information 
Held by Administrative Organs” (Act No. 42 of May 14, 1999). In either case, however, since the 
information on names of physicians, sites, etc. is not subject to reporting, such information will not be 
posted or disclosed. 

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            Protocol No. A8081031 
1
Objectives
This survey examines the safety and efficacy of this drug in daily medical care. It is also 
intended to understand the occurrence of unknown and known adverse drug reactions and 
under the actual use during the survey period and examine the necessity of conducting a 
new special investigation and/or post-marketing clinical study. 
Based on the conditions of approval (because there is an extremely limited number of 
patients for domestic clinical studies, a use-result survey must be conducted for all patients 
until the data on a certain number of patients are collected to understand the background 
information on the patients using this drug and take necessary measures for proper use of 
this drug by collecting the data on the safety and efficacy of this drug early), this survey will 
be an all-patient registration survey until the data on a certain number of patients are 
collected after the marketing of this drug in order to verify the information on adverse drug 
reactions that may occur at an early stage after the use of this drug.
As the priority items to be surveyed, the occurrence of the following events will be studied.
(1) Interstitial lung disease
(2) QTc prolongation
(3) Bradycardia
(4) Hepatotoxicity
(5) Visual disturbance
(6) Neutropenia/leukopenia
(7) Neuropathy
(8) Complex renal cyst
(9) Photosensitivity
2
Patients to be surveyed
An all-patient registration survey will be conducted for all patients who will receive this drug 
(including the patients who have participated in the special medical care coverage) for a certain 
period of time. The indications and dosage and administration of this drug are as follows. 
See the latest package insert when administering this drug.
Indications: ALK fusion gene-positive unresectable, advanced/recurrent non-small
cell lung cancer
Dosage and administration: The usual adult dosage for oral use is 250 mg of 
crizotinib twice daily. The dosage may be decreased according to the 
patient condition.

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             Protocol No. A8081031 
3
Target sample size
The target sample size is 2000 patients with ALK fusion gene-positive non-small cell lung 
cancer treated with this drug (including the patients who have participated in the special medical 
care coverage). 
〔Rationale for setting〕
The incidence of interstitial lung disease among the Japanese patients in the data of global 
clinical trials (Studies A8081001, A8081005, A8081007 and A8081014) was about 3.6% 
(4/111) *. Considering that the incidence of interstitial lung disease among the Japanese 
patients may be higher than that of the foreign patients, the target sample size was examined
by assuming that the incidence of interstitial lung disease caused by this drug is about 4%. 
By referring to the results of a prospective survey (special survey) of gefitinib, special 
investigation of erlotinib, etc., if the incidence of interstitial lung disease among the population 
with high risk for a certain factor (high-risk population) is more than twice the incidence of 
interstitial lung disease among the population with low risk for the same factor (low-risk 
population), we considered setting the sample size so as to detect this population with high 
probability and examined it based on the relations among the sample size, significance level 
and power necessary for a chi-square test. 
When the significance level was 15%, a power curve nearly exhibited a plateau around 2000 
patients. When the sample size was 2000, the power was 90% or higher even if the ratio of the 
sample size between the low-risk population and high-risk population was 1:2 or 2:1 and 
86.3% even if the ratio of the sample size was 1:3. On the other hand, when the significance 
level was 5% with the sample size of 2000 patients, the power was 83.8%, 77.5% and 81.0% 
respectively when the ratio of the sample size was 1:1, 1:2 and 2:1. Furthermore, when the 
ratio was 1:3 and 3:1, the power was 68.4% and 75.8% respectively, demonstrating certain 
power.
Based on the above results, the target sample size of 2000 patients is also a sufficient size 
when examining risk factors that require attention by multivariate analyses such as a Cox 
proportional hazard model.
*Because Studies A8081007 and A8081014 are ongoing open-label randomized studies, half of the patients 
who were treated with the study drug as of December 6, 2011 were counted as the patients treated with
crizotinib
4
Scheduled period of survey
The periods of implementation and registration will be set as follows: 
Survey period : Date of release of this drug in 2012 – not to be set*
Registration period
: Date of release of this drug in 2012 – not to be set*
*The survey and registration periods will continue until the final evaluation by the regulatory 
authority is obtained.
5
Survey methods
5.1
Survey method
The survey will be conducted in an all-patient registration survey method until the sample 
size after the marketing of this drug reaches 2000 patients (patients with ALK fusion 
gene-positive non-small cell lung cancer). In case of using this drug after December 4, 2014, 
only case registration will be continued. Based on the request of Pfizer Inc., in the case where it 
is necessary to collect additional information in cases with case registration using this drug after 
December 4, 2014, the investigative physician Describe the survey form.

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             Protocol No. A8081031 
5.2
Method of data collection
In this survey, the data are collected using the designated “survey form” provided by Pfizer 
Japan Inc. (hereinafter referred to as “sponsor”). The physician in charge of survey will promptly 
fill out the survey form after the end of the observation period for survey form parts, seal the 
survey form in an envelope and submit it to the sponsor. The specific procedures, methods of 
filling out, correcting and verifying the survey form shall be separately stipulated in the sample for 
entry, etc.
5.3
Patient registration
The physician in charge of survey will fill out a site name, medical department name, 
physician’s name, date of entry, contact information to verify the registration, patient 
identification number, patient’s initial (when necessary), date of birth (or age), (scheduled) 
start date of administration, use experience of Xalkori by this patient, contraindications, 
indications, careful administration and verification of other precautions in the “registration 
form” provided by the sponsor and register them prior to the start of administration.
5.4
Observation period
The observation period is 52 weeks from the start date of administration of Xalkori. However, 
for the patients who completed or discontinued the administration of Xalkori, a period up to the 
date of completion or discontinuation will be the observation period.
In this survey, the following part-type survey forms for the observation period are used.
Part 01: From the start of administration until Week 12 (84 days) 
Part 02: From Week 13 (85 days) until Week 24 (168 days)
Part 03: From Week 25 (169 days) until Week 52 (364 days)
5.5
Points to note when filling out, correcting and verifying the survey form
(1) Method of fill-out
The physician in charge of survey will verify the survey items and fill out the data with an 
immortal writing material such as a pen and ballpoint pen based on the medical records and 
results of various tests. For the test results, a copy of the record may be attached. However, 
masking, etc. should be used for personal information so that a patient’s personal information 
Week 12
Week 24
Week 52
Part 01
Part 02
Part 03
PPD

                        Date prepared: April 27, 2012 Ver. 1
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            Protocol No. A8081031 
cannot be identified but the patient’s record such as a patient identification number can be 
determined.
(2) Method of correction
When correcting the content entered, the physician in charge of survey will draw a double line 
(=) so that the original content can be read and affix a correction seal. If there is an inquiry about 
the content from the sponsor, the physician in charge of survey will verify the aforementioned 
medical records again, correct the content in the survey form when necessary and submit it to 
the sponsor again. When correcting the content related to the evaluation of efficacy and safety, 
the reason(s) for correction and date of correction must be entered together in principle. 
(3) Method of verification
After completing the entry and correction of all survey items, the physician in charge of survey 
will verify the entered survey form and re-survey form again and place his/her printed name and 
seal or sign them. 
5.6
Entry of survey form and points to note in patients changing hospital
     If this drug is continuously administered after the patient is transferred to another 
hospital, the following procedures shall be taken: 
(1) Check “Change hospital/medical department” of discontinuation record in the survey 
form of the pretreatment site and enter the information of the transferred site. 
(2) Verify the use experience of this drug in the patient record at the pretreatment site and 
enter the information of the pretreatment site. 
(3) Verify the use experience of this drug in the survey form of the transferred site and enter
the information of the pretreatment site. 
(4) Enter the information after last visit at the pretreatment site in the survey form of the 
transferred site without omission.
(5) Handle the applicable patient as the same patient based on the information obtained 
with the registration form and survey form. 
(6) The sponsor may make an inquiry about the information entered in the survey form when 
necessary. 
6
Survey items and timing of survey
The physician in charge of survey will conduct this survey according to the following 
observation schedule. The physician in charge of survey will register the patients who meet 
the registration criteria after signing a contract of this survey, verify the data including the 
information on patient characteristics at the start of administration and fill out the survey form. 
The physician in charge of survey will verify the observation data after the end of the 
observation period for survey form parts during the observation period or at the time of 
discontinuation if the administration of this drug is discontinued prematurely, fill out the 
survey form, and submit it to the sponsor.
【Observation schedule】
Registration 
form
Survey form

                        Date prepared: April 27, 2012 Ver. 1
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            Protocol No. A8081031 
        
Timing
  
Survey item
At 
registration
*1
Observation period
At start of 
administration
(Part 01)
From start of 
administration
until Week 12 
(Part 01)
From Week
13 until 
Week 24 
(Part 02)
From Week
25 until 
Week 52 
(Part 03)
Patient 
information
ID number
●
○
Patient initial (when 
necessary)
●
○
Sex
●
○
Date of birth or age
●
○
Patient characteristics
(Scheduled) start date of 
administration of Xalkori
●
○
Height/weight
●
Inpatient/outpatient
●
Target diseases, results of 
ALK test
●
Condition of tumor
●
General condition (ECOG 
PS)
●
Other patient 
characteristics 
(e.g. smoking history) 
●
Implementation of imaging 
test of chest prior to the 
administration of Xalkori*2
●
Medical history
●
History of pretreatment 
(history of drug therapy, 
surgery, radiotherapy)
●
Dosing record of Xalkori
●
●
●
Concomitant therapy (history of 
drug therapy, surgery, 
radiotherapy)
●
●
●
Laboratory test
●
●
●
●
Efficacy evaluation (objective 
tumor response)
●
●
●
Pregnancy
●
●
●
Discontinuation record
●
●
●
Verification of survival
●
●
●
Adverse events
●
●
●
●: Item for entry of data, ○: Item for reflection of data
*1 Items to be entered at the time of registering patients
*2 For laboratory findings, the findings prior to the start of administration shall be entered in the section of medical 
history. If any aggravation or new symptom is observed after the start of administration of this drug, they shall 
be entered in the adverse event sections.
6.1
Patient characteristics
Enter the following information at the start of administration of this drug in the survey form.
(1) Height, weight
(2) Division of inpatient/outpatient
(3) Target diseases
(4) Results of ALK test (ALK test method, date of test implemented, test results)
(5) Tumor condition (TNM classification of the target diseases, histopathological diagnosis)
(6) General condition (ECOG-PS)
(7) Other patient characteristics (smoking history, history of occupational and environmental 
exposure to asbestos, pneumoconiosis, administration of highly-concentrated oxygen for the 

                        Date prepared: April 27, 2012 Ver. 1
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             Protocol No. A8081031 
treatment of respiratory disease)
(8) Implementation of imaging test of chest prior to the start of administration of this drug
(9) Medical history (name of disease or syndrome, division of previous or ongoing disease)
(10) History of pretreatment for non-small cell lung cancer (history of drug therapy, surgery and 
radiotherapy)   
Enter the following information from the start of administration of this drug until the observation 
period in the survey form.
Pregnancy and date of delivery/scheduled date of delivery [for women only]
Compare the occurrence of adverse drug reactions and serious adverse drug reactions in the 
patients with or without hepatic function disorder and renal impairment and examine the risk factors.
6.2
Dosing record of this drug
Regarding the use of this drug from the start of administration of this drug until the end of the 
observation period (or date of discontinuation), enter the following information. In this survey, the 
administration record of this drug is defined as the dosing record. 
(1) One-time dosing amount
(2) Daily dosing frequency
(3) Dosing period
(4) Reason for change/washout
6.3
Concomitant drug therapy
Regarding the drugs other than this drug used from the start of administration of this drug until 
the end of the observation period (or date of discontinuation), enter the following information. If any 
adverse event is noted, enter the drugs administered from the start date until the onset of the 
adverse event and drugs administered for the treatment of the adverse event. 
(1) Drug name
(2) Division of dosage form
(3) One-time dose, daily frequency of administration
(4) Administration period
(5) Procedures taken for the adverse event
6.4
Surgical history for non-small cell lung cancer
Regarding the history of surgery performed from prior to the administration of this drug until the 
end of the observation period (or date of discontinuation), enter the following information.
(1) Site (primary tumor, metastatic tumor)
(2) Date of implementation
6.5
History of radiotherapy for non-small cell lung cancer
Regarding the history of radiotherapy performed from prior to the administration of this drug until 
the end of the observation period (or date of discontinuation), enter the following information.
(1) Site
(2) Total dose
(3) Period of implementation
6.6
Laboratory test
Provide the test slips of the laboratory tests performed from prior to the administration of this 
drug until the end of the observation period (or date of discontinuation).
・Hematology test (red blood cell count, hemoglobin, white blood cell count, differential 
leukocyte count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), platelet 
count)
・Biochemistry test (total bilirubin, AST (GOT), ALT (GPT), AL-P, BUN, serum creatinine)

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            Protocol No. A8081031 
6.7
Efficacy evaluation (objective tumor response)
Evaluate the efficacy of this drug using the items for response evaluation described in the 
“New Guidelines for Response Evaluation Criteria in Solid Tumors (RECIST) – Revised Version 
1.1” for each survey form part and enter the results. 
Determine the objective tumor response according to the Determination for Objective Tumor 
Response: RECIST Criteria. In the classification of tumor lesions at the start of administration of 
this drug, identify target lesions and non-target lesions, check the presence or absence of any 
new lesion in addition to the results of determination of the objective tumor response in each 
tumor lesion site during the observation period and determine the overall response. 
(1) Presence or absence of target lesion at the start of administration of this drug (Yes, No)
(2) Evaluation after the start of administration of this drug
・Presence or absence of implementation
・Date of response evaluation
・Overall response (CR, PR, SD, PD, unevaluable)
6.8
Discontinuation record (reason for discontinuation)
Whether the treatment with this drug should be continued or not will be verified at the end 
of the observation period (or date of discontinuation). If the treatment with this drug cannot 
be continued, select and enter the applicable major reason for discontinuation from the 
following reasons. If the adverse event was selected, enter the data in the adverse event 
section. 
(1) Insufficient clinical response
(2) Adverse event
(3) Patient death
(4) No return to hospital
(5) Change of hospital/medical department
(6) Other (in the case of “Other,” enter the reason. Example: Patient’s will, etc.)
Supplement: In the case of patient death, select “Patient death” in the verification of survival 
and enter the related information in the adverse event section. In the survey, a period from the 
start of administration of this drug until the date when the patient’s death was confirmed 
regardless of the cause of death will be defined as a survival period. 
6.9
Verification of survival
Verify the survival of patients at the end of the observation period (or date of discontinuation). 
If the death was confirmed, select the applicable major reason for death from the following 
reasons. If progression of non-small cell lung cancer or other was selected, enter the data in the 
adverse event section. 
(1) Survival
(2) Death
[Cause of death]
・Progression of non-small cell lung cancer
・Other
・Unknown
6.10 Verification of adverse events corresponding to priority survey items
If no adverse event corresponds to priority survey items other than the adverse event(s) 
entered in the adverse event section, tick a check box.

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            Protocol No. A8081031 
6.11 Adverse events
Verify the occurrence of adverse events after the start date of administration of this drug 
until the end of the observation period (or date of discontinuation). If any adverse event was 
observed, the physician in charge of survey will take appropriate procedures, promptly inform 
the sponsor according to the “Report of Adverse Events” (Attachment 1) and, in principle,
verify the outcome and progress of the adverse event until its symptom disappears. If “the 
patient or his partner became pregnant or if the physician in charge of survey learns the 
pregnancy during the administration of this drug regardless of the presence or absence of 
adverse events” and if the physician in charge of survey learns the additional information, the 
physician in charge of survey will contact the sponsor. See “Report of Adverse Events”
(Attachment 1) for the details.  
If the sponsor determines it necessary, the detailed survey will be performed separately.
(1) Occurrence of adverse event for the patients who developed intrauterine exposure, 
serious adverse drug reactions, adverse drug reactions not listed in the package inserts, 
etc. 
(2) Adverse event name
(3) Onset date
(4) CTCAE v4.0 Grade (at worst)
(5) Procedures
(6) Seriousness
(7) Outcome of adverse event to date
(8) Causal association with this drug
If the adverse event is related to visual disturbance or laboratory test value, etc., enter the 
following information in addition to the above survey items. 
<Visit to Department of Ophthalmology as a result of visual disturbance and change in 
CTCAE v4.0 Grade>
(1) Adverse event name of visual disturbance
(2) CTCAE v4.0 Grade at onset of adverse event
(3) CTCAE v4.0 Grade at worst of adverse event
(4) CTCAE v4.0 Grade at outcome of adverse event
(5) Visit to Department of Ophthalmology
<Test related to the adverse event>
(1) Test name
(2) Baseline at site
(3) Unit
(4) Date of measurement
(5) Result
Supplement: An adverse event is any untoward event (including clinically problematic 
abnormal fluctuations of laboratory test values) for patients that occurred after the 
administration of this drug regardless of the causal association with this drug. A serious 
adverse event is an event that (1) results in death, (2) is life-threatening, (3) requires 
inpatient hospitalization or prolongation of existing hospitalization, (4) results in 
persistent or significant disability/incapacity, (5) is a congenital anomaly/birth defect,, 
(6) is other medically important event, or (7) may lead to impairment or damage.
6.11.1
Detailed information of adverse events related to interstitial lung disease
If interstitial lung disease occurs, fill out the Appendix 2 (Interstitial Lung Disease) regardless 
of the causal association with this drug. The sponsor will ask to provide the results of chest CT 
and x-ray tests (image photos or data), while the physician in charge of survey will send the test 
results along with the survey form to the sponsor.

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            Protocol No. A8081031 
6.12 Priority survey items
The occurrence of the following priority survey items will be examined in this survey. 
If the sponsor determines it necessary, the detailed survey will be performed for the patients 
who fall under the category of the priority survey items.
(1) Interstitial lung disease
(2) QTc prolongation
(3) Bradycardia
(4) Hepatotoxicity
(5) Visual disturbance
(6) Neutropenia/leukopenia
(7) Neuropathy
(8) Complex renal cyst
(9) Photosensitivity
(1) Interstitial lung disease
Collect the information on the occurrence (including seriousness), medical history (e.g. past 
history of interstitial lung disease, the disease condition), concomitant medications, procedures 
(including reaction to the procedures), progress after the procedures, duration from the start date 
of administration of this drug until the onset date, duration from the onset date until the date of 
recovery, and judging comments by the physician. Also, for the patients who developed
interstitial lung disease, obtain the data of image findings of chest CT test, etc. related symptoms, 
treatment for interstitial lung disease and the effect and related tests including respiratory test. 
Verify the past history of interstitial lung disease or the disease condition, etc. at the time of 
registration of this drug and collect the information on the aforementioned occurrence, 
concomitant medications, etc. after the start of the administration. Based on the information 
collected from the registration and survey forms, evaluate the occurrence of interstitial lung 
disease caused by the administration of this drug. Furthermore, the patient characteristics will be 
tabulated, analyzed and evaluated by occurrence of interstitial lung disease.
(2) QTc prolongation
Collect the information on the occurrence, medical history, concomitant medications, 
procedures, progress after the procedures, duration from the start date of administration of this 
drug until the onset date, and judging comments by the physician. Also, obtain the data of ECG 
and electrolytes. Collect the information by verifying the past history of QTc prolongation at the 
time of registration of this drug and filling out the registration form. Based on the information 
collected from the registration and survey forms, evaluate the occurrence of QTc prolongation
caused by the administration of this drug.
(3) Bradycardia
Collect the information on the occurrence, medical history, concomitant medications, 
procedures, progress after the procedures, duration from the start date of administration of this 
drug until the onset date, and judging comments by the physician. Also, obtain the data of heart 
rate and electrolytes. Based on the information collected from the survey form, evaluate the 
occurrence of bradycardia caused by the administration of this drug.
(4) Hepatotoxicity
Collect the information on the occurrence, medical history (e.g. past history of lung disease or 
the disease condition), presence or absence of aggravation of metastases to lung, concomitant 
medications, procedures, progress after the procedures, duration from the start date of 
administration of this drug until the onset date, biochemistry test (e.g. AST, ALT, total bilirubin), 
data of related tests (including hepatitis screening), and judging comments by the physician.
Verify the presence or absence of hepatic function disorder at the time of registration of this drug 
and collect the information by filling the condition in the registration form. Based on the 
information collected from the registration and survey forms, evaluate the occurrence of 
hepatotoxicity caused by the administration of this drug. Furthermore, the patient characteristics 
will be tabulated, analyzed and evaluated by occurrence of hepatotoxicity.

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             Protocol No. A8081031 
(5) Visual disturbance
Collect the information on the occurrence, concomitant medications, procedures, progress 
after the procedures, duration from the start date of administration of this drug until the onset 
date, duration from the onset date until the date of recovery (duration of visual disturbance), 
changes in CTCAE v4.0 Grade, and judging comments by the physician. For the patients who 
visited a department of ophthalmology, obtain the date of visit, presence or absence of 
ophthalmologic examination, type and results of the ophthalmologic examination and the 
diagnosis by the ophthalmologist. Based on the information collected from the survey form, 
evaluate the occurrence of visual disturbance caused by the administration of this drug. 
Furthermore, the patient characteristics will be tabulated, analyzed and evaluated by occurrence 
of visual disturbance.
(6) Neutropenia/leukopenia
Collect the information on the occurrence, concomitant medications, procedures, progress 
after the procedures, duration from the start date of administration of this drug until the onset 
date, hematologgy test data (red blood cell count, hemoglobin, white blood cell count, differential 
leukocyte count, platelet count), and judging comments by the physician. At the time of 
registration of this drug, collect the baseline information of neutrophil count, platelet count and 
hemoglobin with the registration form. Based on the information collected from the registration 
and survey forms, evaluate the occurrence of neutropenia/leukopenia caused by the 
administration of this drug. Furthermore, the patient characteristics will be tabulated, analyzed 
and evaluated by occurrence of neutropenia/leukopenia.
(7) Neuropathy
Collect the information on the occurrence, concomitant medications, procedures, progress 
after the procedures, duration from the start date of administration of this drug until the onset 
date, and judging comments by the physician. Based on the information collected from the 
survey form, evaluate the occurrence of neuropathy caused by the administration of this drug. 
Furthermore, the patient characteristics will be tabulated, analyzed and evaluated by occurrence 
of neuropathy.
(8) Complex renal cyst
Collect the information on the occurrence, concomitant medications, procedures, progress 
after the procedures, duration from the start date of administration of this drug until the onset 
date, and judging comments by the physician. For the patients who developed complex renal 
cyst, obtain the data on related symptoms, urinalysis, abdominal CT test and renal biopsy. Based 
on the information collected from the survey form, evaluate the occurrence of complex renal cyst 
caused by the administration of this drug. 
(9) Photosensitivity
Collect the information on the occurrence, concomitant medications, procedures, progress 
after the procedures, duration from the start date of administration of this drug until the onset 
date, and judging comments by the physician. Based on the information collected from the 
survey form, evaluate the occurrence of photosensitivity caused by the administration of this 
drug. 
7
Analysis plan
7.1
Analysis set
Basically, the patients who were confirmed to have taken this drug at least once will be the 
subjects for safety analysis. Also, the patients who have at least one measurable lesion and 
received the efficacy evaluation will be the subjects for efficacy analysis according to the analysis 
plan which will be separately specified. 
7.2
Analysis method
(1) Analysis for safety evaluation
Major analysis items will be the occurrence of adverse drug reactions and interstitial lung 

                        Date prepared: April 27, 2012 Ver. 1
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            Protocol No. A8081031 
F a x    N o .
03-5309-9186
M a i l  a d d r e s s
XLK_SI_PMS@pfizer.com
10 Attachment
Attachment 1: Report of Adverse Events