SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -
Conditions: Renal Cell Carcinoma
Sponsor: Pfizer

For application of re-examination
TORISEL 25 mg Injection
Special Investigation
All patient surveillance 
Protocol
Pfizer Japan Inc.
Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Versions 2
Protocol ID: B1771015

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
INTRODUCTION
TORISEL 25 mg Injection (hereinafter called this drug) is a m-TOR inhibitor. This drug acts by inhibiting 
mTOR (mammalian target of rapamycin), which is a kinase regulating the growth and proliferation of cancer 
cells. It was granted the marketing authorization in Japan on July 23, 2010 with an indication of metastatic 
and/or unresectable renal cell carcinoma.
Special Investigation of TORISEL 25 mg Injection - All patient surveillance - (hereinafter called this study) is 
intended to confirm the effectiveness and safety of this drug in daily clinical settings, examine the onset state of 
adverse events and potentially influencing factors (particularly, those designated as major investigation items), 
and examine the onset state and potential onset risk factors of interstitial lung disease. The information obtained 
in this study shall be used to provide proper-use information, and to prepare documents for the re-examination 
application. This study, therefore, shall be conducted in strict compliance with the "MHLW Ordinance on the 
Standard for Post-Marketing Studies and Clinical Trials of Medical Products" (MHLW Ordinance No. 171, dated 
December 20, 2004). Data obtained from the patients registered in this study will be reported to the MHLW 
pursuant to the Pharmaceutical Affairs Law, pertinent to which may be publicly posted in MHLW's 
"Pharmaceutical and Medical Device Safety Information" and "Pharmaceuticals and Medical Devices 
Information Website (http://www.info.pmda.go.jp)" as a listing of patients, which will present the names of drugs, 
adverse reactions, gender, age (increment of 10 years), and other relevant information. Furthermore, data 
collected may also be disclosed if the MHLW is required to disclose such information in accordance with the 
"Act on Access to Information Held by Administrative Organs" (Law No. 42 dated May 14, 1999); provided that 
in no event will the names of investigators, sites, and other personal information be subject to such disclosure, 
nor will it be posted or disclosed in any form or shape.

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
1
OBJECTIVES
The objective of this study is to assess the following subject matters in patients treated with TORISEL 25 mg 
Injection (hereinafter called this drug) in post-marketing actual use conditions, thereby providing proper-use 
information. 
(1)
To confirm the effectiveness and safety of this drug under actual use conditions
(2)
To examine the onset state of adverse events and potentially influencing factors (particularly, major 
investigation items)
(3)
To examine the onset state and potential onset risk factors of interstitial lung disease
[Conditions for approval]
A drug use investigation must be conducted with all the patients treated with this drug until the data from 
a specified number of cases are accumulated after the marketing of this drug in order to understand the 
background information on patients treated with this drug, collect the data on the safety and effectiveness
of this drug as early as possible, and take necessary measures to ensure the proper-use of this drug.
2
PATIENTS
This study will be conducted with all patients treated with this drug in a specific period of time. The indications 
and dosage and administration of this drug are described below.
[Indications]
Metastatic and/or unresectable renal cell carcinoma
[Precautions Regarding Indications]
1.
The efficacy and safety of TORISEL as postoperative adjuvant chemotherapy has not been 
established.
2.
The selection of patients in whom to administer TORISEL must be performed after thorough 
consideration of the efficacy and safety data based on understanding of information detailed in
"Clinical Studies*".
* Refer to the [Clinical Studies] section in the package insert.
[Dosage and Administration]
The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via intravenous infusion 
over 30 - 60 minutes. The dosage is to be appropriately reduced according to patient’s condition.
[Precautions regarding dosage and administration]
1.
The efficacy and safety of TORISEL in combination use with other anti-malignant tumor agents 
including cytokine preparations have not been established.
2.
When interstitial lung disease occurs, interrupt/discontinue administration depending on the 
symptoms and severity with consideration of the following criteria:

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
Criteria for interruption or discontinuation in case of interstitial lung disease
Symptom
Intervention
Asymptomatic. 
Only 
abnormal 
imaging 
findings are observed. 
Continue to administer. 
Mild clinical symptoms Note) (not interfering 
activity of daily living)
Interrupt administration until the symptoms 
recovered. 
Severe clinical symptoms Note) (interfering with 
activity of daily living and need oxygen 
therapy)
Discontinue
Aggravation 
of 
clinical 
symptoms 
and 
pulmonary diffusing capacity decreased
Underlying pulmonary disease, with changes 
in clinical or image findings are observed
Note: Dyspnea, cough, etc.
3.
If severe adverse reactions (Grade 3 or severer) occur other than interstitial lung disease, interrupt 
administration of TORISEL until resolution of the adverse reaction. If the adverse reaction is 
resolved within 3 weeks, administration can be resumed at a reduced dose by one level (reduction 
levels should proceed as follows: initial dose 25 mg -> 20 mg-> 15 mg -> 10 mg).
4.
To avoid infusion reactions, an antihistamine (e.g., d-chlorpheniramine maleate, diphenhydramine
hydrochloride, etc.) should be administered prior to the administration of TORISEL. If infusion 
reactions occur, stop administration immediately.
5.
When administering TORISEL, do not use infusion kits containing DEHP [di-(2-ethylhexyl) 
phthalate] as a plasticizer.
6.
An in-line filter with a pore size of not greater than 5 μm should be used for TORISEL infusion. 
7.
Dose reduction should be considered for patients with severe hepatic function disorder.
3
STUDY SIZE
All the patients treated with this drug will be included in the all patient surveillance to be conducted for a 
specific period of time. 
Target number of cases: 600 cases
Target number of cases observed: 300 cases treated for 12 weeks or longer (300 cases with Booklet 03 
case report form)
(Cases who discontinued the drug before 12 weeks will also be included.)
[Rationale]
The incidence of all the adverse events included in the major investigation items of this study was 1.0% or 
higher in the drug group of the foreign phase 3 clinical study (304-WW Study). Assuming that the true 
incidence of an adverse event (particularly an adverse event included in the major investigation items) is 1.0%, 
300 cases are required to observe at least 1 case with the event at a probability of at least 95%. The incidence of 
interstitial lung disease was 17.1% (14/82) in the multinational (Asian) phase 2 clinical study (2217-AP Study). 

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
Assuming that the true incidence of interstitial lung disease is 17.1%, at least 40 cases with the disease can be 
observed at a probability of at least 95%.
Further, clinical study results showed that interstitial lung disease occurred on Week 4 after the start of the drug 
or later, and that, in rare cases, some adverse events had an increased incidence or delayed onset as the 
administration period was prolonged. Considering these results, it was decided to set a target that this study
would include 300 cases treated with this drug for 12 weeks or longer. 
Clinical study results showed that this drug could be continued for 12 weeks or longer in about 60% of the 
whole treated cases, with a discontinuance/drop-out rate at 12 weeks of about 40%. Considering that this study
will be conducted under actual use condition, it is assumed that the discontinuance/drop-out rate at 12 weeks in 
this study will be increased by 10% to 50%. That is, it is assumed that this drug will be continued for 12 weeks 
or longer (the Booklet 03 case report form will be collected) in 50% of the cases included in this study.
Therefore, this surveillance was planned to register 600 cases to collect 300 cases treated with this drug for 
12 weeks or longer. In addition, because cases which discontinue the drug before 12 weeks will be included in 
the study, the case report form will be collected from them to evaluate safety and effectiveness.
4
PLANNED INVESTIGATION PERIOD
Study period*:
September 2010 (launch of this drug) to August 2012 (2 years)
Registration period: September 2010 (launch of this drug) to
The cases treated with this drug after the initial 600 cases will be registered, but not studied.
* However, this study will be conducted until March 2014 when the separate Special Investigation on 
long-term use is included (cumulative study period: 3 years and 6 months).
5
STUDY PROCEDURES
5.1
Study method
This study will be conducted with all the patients treated with this drug until the data from a specified number 
of cases are accumulated after the marketing of this drug in order to understand the background information on 
patients treated with this drug, collect data on the safety and effectiveness of this drug as early as possible, and 
take necessary measures to ensure the proper-use of this drug. This study will be conducted as all patient 
surveillance system at sites with investigators who have sufficient knowledge and experience about drug 
therapy for renal cancer.

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
(1)
Conduct of prior explanation 
Medical representatives (MRs) will explain the safety and effectiveness of this drug to investigators 
and pharmacists expected to use the drug using the materials for providing safety information.  
[Materials for providing safety information] 
-
Package insert
-
Explanation to "Precautions for Use" of new drugs
-
Interview Form
-
Proper-use guide
-
Summary of general product information
(2)
Study contract 
After the prior explanation, a contract will be made with each site on this study. A specific contract 
form of a site, if any, will be used. This drug will be supplied to each site after the contract with the 
institution is made.
5.2
Data collection method
In this study, the case report form provided by the sponsor will be used to collect data when the sponsor asks 
sites to use it. When the sponsor asks sites to use the specific case report form to collect data, the investigator in 
each site will readily fill in the form and submit it to the sponsor.
5.3
Patient registration
(1)
Registration procedure
The investigator will complete the registration form on patients treated with this drug provided by 
sponsor, and submit the form to Patient Registration Center via FAX at treatment.
[TORISEL Patient Registration Center] 
Fax number:
0120-655-781 (available 24 hours)
Business hours:
9:00 to 18:00*
(except for Saturdays, Sundays, National Holidays, and New Year Holidays)
*FAX transmission after 17:30 will be responded by 9:30 on the following business day.
(2)
Case registration
After the patient was registered, "the announcement of the patient registration" will be sent to the 
investigator by FAX. Investigator will save the announcement in the site.
If there is something to be confirmed found in the registration form, confirmation will be requested 
with the investigator. In the case of confirmation, "request form of confirmation" and "registration 
form (copy)" will be sent from the Registration Center to the investigator by FAX.
(3)
Confirmation of registered case 
At the end of the registration period, each investigator will confirm that all his/her cases treated with 
this drug are listed in the "TORISEL Special Investigation Registration List," and submit it to MR in 
charge with his/her signature or print of his/her name with his/her seal. 
When an investigator finds a case treated with the drug, but not registered in the list, the investigator
will readily register the case.

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
5.4
Observation period 
The observation period for this study will be set until Week 24 after the start of administration (cases treated 
with the drug for more than 25 weeks will be included in the separately planned Special Investigation on 
long-term use and observed for up to 96 weeks after the start of administration)
Clinical evaluation of tumor: Weeks 8, 16, and 24. For discontinued cases, if the clinical evaluation of tumor is 
not performed within 4 weeks prior to discontinuation, clinical evaluation of tumor will be 
performed at the time of discontinuation.
Adverse events: 
Until Week 24 after the start of administration. If the drug is discontinued before Week 24, 
observe until Day 28 after the discontinuation of administration.
This study will be conducted using a case report form divided into separate booklets. The results during the 
following observation periods will be recorded in the different booklets of the case report form. 
Booklet
Observation period
Booklet 01
Start of administration to Week 4 (Day 28)
Booklet 02
Week 5 (Day 29) to Week 12 (Day 84) after start of 
administration
Booklet 03
Week 13 (Day 85) to Week 24 (Day 168) after start of 
administration
Observation period and evaluation time points for each booklet of case report form
(Start of administration)
(Day 1)
Booklet 01
(Observation 
period
Until Week 4)
Booklet 02
(Observation period
Week 5 to Week 12)
Booklet 03
(Observation period
Week 13 to Week 24
* Continued cases will 
be re-registered and 
transferred to Special 
Investigation on 
long-term use.
: The safety evaluation results during the observation 
period will be recorded in the case report form. 
: The effectiveness evaluation results during the observation 
period will be recorded in the case report form. 
Special 
Investigation
(Long-term use)
Continued 
cases
Re-registration*
Week 16
Week 8
Week 4
Week 12
Week 24

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
5.5
Reminders concerning completing, revising, and reviewing of case report forms
(1)
The investigator shall, upon confirming the study items, complete the case report form based on 
medical charts and other medical records such as relevant test results, using a pen, ballpoint pen, or 
other inerasable means.
(2)
When the investigator receives an inquiry from Pfizer Japan Inc. (for data confirmation), he/she will 
reconfirm the above medical records and, if necessary, correct and re-submit the case report form. 
When the investigator corrects a part of the case report form, he/she will draw a double line on the 
part so that the original entry is kept visible and put a correction seal. When the confirmation
investigator corrects a part related to evaluation of effectiveness or safety, in principle, he/she will 
record the reason and date of correction. 
6
INVESTIGATION ITEMS AND SCHEDULE
The investigator will conduct the study according to the following schedule of observation. After the 
conclusion of the study contract, the investigator will register patients who meet the registration conditions, 
check their data including the background information at the start of administration, and fill in the case report 
form (at patient registration and at the start of administration). In the observation period, the investigator will 
check their follow-up data at the end of the observation period of each booklet of the case report form or at 
discontinuation when the drug is discontinued, record the data to the case report form and submit it to the 
sponsor. 

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
[Observation schedule]
Observation and evaluation time points
At the start of 
administration
Starting date of 
administration to 
Week 4 (Day 28)
Weeks 5 to 12 
after start of 
administration
Weeks 13 to 24
after start of 
administration
Registration 
information
ID number, patient initials, 
gender, date of birth (age), 
scheduled date to start 
administration, and availability of 
pre-treatment chest CT
●
Patient background
●
Clinical history
●
Prior treatment history
●
Record of TORISEL treatment
Concomitant therapy (drug therapy)
Concomitant therapy (non-drug therapy)
Examination (chest CT)
●
●
●
●
Examination (chest X-rays)
●
●
●
●
Examination (clinical laboratory testing)
●
●
●
●
Effectiveness evaluation*
Week 8
Week 16
Week 24
Pregnancy status
●
●
●
Patient summary (continuation/discontinuation
status)
●
●
●
Adverse events
Detailed information on adverse events related to 
interstitial lung disease
(Attachment: detailed case report form)
* For discontinued cases, if the clinical evaluation of tumor is not performed within 4 weeks prior to 
discontinuation, clinical evaluation of tumor will be performed at the time of discontinuation.
6.1
Background
(1)
The following information will be recorded to the registration form at the start of this drug
administration. 
[1]
ID number
[2]
Patient initials (as required)
[3]
Gender
[4]
Date of birth (age)
[5]
Scheduled date to start administration
[6]
Availability of pre-treatment chest CT 
(2)
The following information will be recorded to the case report form at the start of this drug
administration. 
[1]
Height, body weight, and hospitalization status
[2]
Disease to be studied and date of diagnosis

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
[3]
State of tumor (TNM classification, metastatic status at the start of this drug, and 
histopathological diagnosis)
[4]
Performance status (ECOG PS)
[5]
MSKCC risk classification (LDH, albumin, calcium, and Karnofsky performance status at the 
start of administration); the other items of the MSKCC risk classification will be calculated from 
the patient background information and laboratory test results.
[6]
Other patient background information (smoking history, familial history of diabetes, lung 
surgery history, prior use of steroids, occupational and environmental exposure to asbestos and 
pneumoconiosis, prior administration of high concentration oxygen to treat respiratory diseases, 
and history of drug and non-drug allergies 
[7]
Clinical history (history of diseases and complications)
[8]
Presence/absence of hepatic/renal dysfunction 
[9]
Prior treatment history (history of surgery, radiotherapy, other non-drug therapy, and drug 
therapy for renal cell cancer) 
6.2
Targeted drug use record
The following TORISEL use information will be recorded for each observation period.
[1]
Date of administration
[2]
Dose
[3]
Reason for dose change
6.3
Concomitant therapy
6.3.1
Drug therapy
The following information will be recorded in each booklet of the case report form for all the drugs 
administered from the start date of the observation period to the date of safety evaluation. If an adverse event is 
noted, the drugs used during the period from the start day of the observation period to the onset of the adverse 
event and medications used for treatment of the adverse event should also be recorded.
[1]
Drug name (product name)
[2]
Administration route
[3]
Daily dosage
[4]
Daily dosing frequency
[5]
Administration period
[6]
Reason for the administration
6.3.2
Non-drug therapy
The following information will be recorded in each booklet of the case report form for the non-drug therapy
given from the start date of the observation period to the safety evaluation date. If an adverse event is noted, the 
non-drug therapy used during the period from the start day of the observation period to the onset of the adverse 
event and non-drug therapy used for treatment of the adverse event should also be recorded.
[1]
Name of therapy 
[2]
Therapeutic period 
[3]
Reason for the therapy 

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
6.4
Tests / Clinical laboratory tests
[1]
Chest CT examination 
[2]
Chest X-ray examination 
[3]
SpO2, KL-6, SP-D, SP-A
[4]
Hemoglobin, white blood cell count, white blood cell differentiation (neutrophil count), and 
platelet count 
[5]
AST, ALT, total bilirubin, and ALP 
[6]
Total cholesterol and triglyceride 
[7]
Fasting blood sugar and HbA1c 
[8]
BUN and serum creatinine
[9]
Potassium and phosphoric acid
[10] CRP
6.5
Effectiveness evaluation
6.5.1
Clinical evaluation of tumor
Clinical evaluation of tumor will be performed at Weeks 8, 16, and 24 after the start of administration. The 
presence/absence of the target, non-target, and new lesions will be evaluated at each evaluation time point. The 
evaluation will be performed using the following 4 classes with reference to the "New response evaluation 
criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version." 
Complete response
(CR)
Disappearance of all target regions
Partial response
(PR)
At least a 30% decrease in the sum of the longest diameter (LD) of 
target lesions, taking as reference the baseline sum LD 
Progressive disease
(PD)
At least a 20% increase in the sum of the LD of target lesions, taking as 
reference the smallest sum LD recorded since the treatment started
Stable disease
(SD)
Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum LD since the 
treatment started
6.6
Patient background (at the completion)
The pregnancy status between the starting date of administration and safety evaluation date and actual/expected
date of delivery will be recorded (for female patients only). 
6.7
Patient summary (reason for discontinuation)
Continuation or discontinuation of the treatment with this drug is determined on the safety evaluation date.
When it is determined that the treatment with this drug cannot be continued, the major reason of discontinuance 
will be selected from the following options and recorded (multiple selection not permitted). Appropriate data 
will be recorded to the adverse event section of the form when any of the following options is selected: [2]
adverse event, [3] abnormal laboratory test value, or [4] patient's death. 
[1]
Insufficient clinical effectiveness
[2]
Adverse event
[3]
Abnormal laboratory test value
[4]
Patient's death (date of death)

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
[5]
Lost to follow-up (reason) 
[6]
Others (specify the reason, such as treatment completed because of cure)
6.8
Adverse event
To evaluate safety, the onset of adverse events after the start of the drug administration will be investigated and 
the following information (1) to (9) will be recorded. In principle, each adverse event will be followed until 
each safety evaluation date. If an adverse event occurs, the investigator will give appropriate treatment, readily 
notify the sponsor as specified in the "Adverse Event Reporting" (attachment), and, in principle, follow its 
outcome and clinical course until its symptom is resolved. Particularly, the investigator will call by phone the 
following contact number within 24 hours "when a serious adverse event occurs", "when a patient or his/her 
partner becomes pregnant or is found to be pregnant during the treatment with this drug regardless of the onset 
of adverse events", or when the investigator knows any additional information on the adverse event or 
pregnancy. For details, refer to the "Adverse Event Reporting" (attachment). 
Contact number in case of serious adverse event
[TEL]
0120-099-526 (toll-free)
[Business hours]
9:00 to 18:00
(available every day of the year)
In addition, a detailed study will be separately conducted for intrauterine exposure, serious adverse reactions, or 
adverse reactions not listed in the package insert, etc., if deemed necessary by the sponsor. 
[1]
Date of safety evaluation
[2]
Presence/absence of adverse events 
[3]
Adverse event name (disease or symptom name)
[4]
Date of onset
[5]
CTCAE v4.0 Grade
[6]
Treatment 
[7]
Seriousness
[8]
Current outcome of adverse event
[9]
Causal relationship
Important:
Adverse events are any and all unfavorable events (including clinically significant abnormal 
changes in laboratory tests) occurring in patients after starting the target drug treatment 
regardless of their causal relationship. Serious adverse events are any unfavorable medical 
occurrences that result in death, are life-threatening, require (or prolong) hospitalization, cause 
persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or 
are other conditions which represent significant health hazards. 

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
Supplementary information:
The progress of the target malignant tumor will not be recorded as an adverse event. However, 
any malignant tumor that reaches a lethal outcome during the observation period has to be 
recorded as an adverse event. When a patient starts a new treatment, the reportable period of the 
event will end when the new treatment is started.
6.8.1
Detailed information on adverse events related to interstitial lung disease
When interstitial lung disease occurs, the attachment (detailed case report form) will be recorded separately.
The sponsor will request the site to provide the results of chest CT and/or chest X-rays (images or data).
6.9
Major investigation items
The following events should be evaluated in this study as major investigation items. 
[1]
Interstitial lung disease 
[2]
Dyspnea
[3]
Diabetes/hyperglycaemia 
[4]
Hypersensitivity reaction 
[5]
Diarrhoea
[6]
Hypophosphataemia
[7]
Hypokalaemia
[8]
Hypercholesterolaemia/hyperlipidaemia 
[9]
Infections 
[10] Intracerebral hemorrhage 
[11] Wound healing abnormal
[12] Mucositis related adverse events
[13] Skin disorder
[14] Acute renal failure
[15] Gastrointestinal perforation
[16] History of infection with hepatitis B, tuberculosis, or herpes zoster
For patients who develop any adverse event in the above major investigation items, a separate detailed survey
as specified in the attachment will be conducted if deemed necessary by the sponsor.
7
STATISTICAL ANALYSIS PLAN
7.1
Analysis Set
As a rule, the safety analysis set will include patients who satisfy the eligibility criteria and confirmed to be 
treated with this drug at least once. As a rule, the effectiveness analysis set will include patients who are
evaluable for effectiveness (patients considered to have received appropriate evaluation). The details of the 
analysis sets will be specified in a statistical analysis plan.

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
7.2
Method of Analysis
7.2.1
Analysis for safety evaluation
The following items will be mainly analyzed in the safety analysis population. 
The analytical method for the major investigation items will be specified in the statistical analysis plan, in 
accordance with the objective of analysis.
[1]
Onset state of adverse events/adverse reactions (particularly the major investigation items)
[2]
Onset state of adverse reactions and potential influencing factors (particularly the major 
investigation items)
[3]
Safety in patients with special background (pediatric patients, elderly patients, pregnant women, 
patients with renal or hepatic dysfunction)
[4]
Safety in patients with hepatic dysfunction (including the comparative examination with results 
from the foreign phase 1 clinical study)
[5]
Onset state of interstitial lung disease (including asymptomatic cases with imaging findings of 
the disease)
[6]
Potential risk factors of interstitial lung disease 
[7]
Characteristics of interstitial lung disease (imaging findings, onset timing, duration, and 
breakdown by severity)
[8]
List of clinical course of interstitial lung disease (contents of treatment, response to treatment, 
and outcome) and clinical course after the drug is restarted (presence/absence of 
recurrence/exacerbation, etc.)
[9]
Onset state of various related events suspected of causing
interstitial lung disease 
(pneumonitis/lung infiltration and pulmonary fibrosis, etc.)
7.2.2
Analysis for effectiveness evaluation
The response rate and clinical benefit rate as shown below will be used as main analytical items in the 
effectiveness analysis set. An 
 analysis including the examination of factors influencing 
effectiveness will be performed, as required. 
[1]
Response rate (rate of CR + PR)
[2]
Clinical benefit rate (Rate of cases with CR + PR + SD maintained for 24 weeks or longer)
8
DISSEMINATION OF THE RESULTS
Pfizer Japan will comply with a responsibility to publish the present study results by posting them on 
ClinicalStudyResults.org. Pfizer Japan will disclose the results of the study that meets either of below. As 
needed, Pfizer Japan will publish the study results (journals or at the academic society meetings) to provide the 
proper-use information of this drug.
-
The study registered to www.clinicaltrials.gov (ClinicalTrials.gov) by Pfizer Japan, regardless of the 
reason for such registration.
-
Other than above, the study whose results are considered important by Pfizer Japan from the scientific or 
medical view point.
The timing of public release is dependent on the presence of any country with approval of the product at the 
time of completion of the study.
-
Any study involving an already-approved Pfizer product in any country will require Pfizer Japan to 
publicly release the results within 1 year of the finalization of last-patient last-visit (LSLV) data. 
CCI

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Date of preparation: August 24, 2010, Version 1
Date of revision: February 2, 2011, Version 2
Protocol ID: B1771015
Pfizer Japan will post the following items in ClinicalStudyResults.org.
-
Title of post-marketing surveillance protocol, developmental stage, and target disease
-
Labeling of approved product
-
Outline of study results 
-
References to published papers
-
Disclaimer
The study results will be posted on ClinicalStudyResults.org (Pharmaceutical Research and Manufacturers of 
America [PhRMA] website synopsis [PWS]) according to the form specified in ICH E3. When an intended 
posting of study results on ClinicalStudyResults.org may interfere with a planned posting of other study results, 
a statement that the publication of the results is reserved will be posted instead of the outline of the study
results. The posting period of the statement will be until the publication of the study results or 2 years after the 
completion of the study, whichever comes first. 
Literature references to be used will be limited to those widely recognized and accessible through searchable 
literature databases.
9
CONTACT INFORMATION
 
10 REFERENCES
Package Insert of TORISEL 25 mg Injection
Attachment: Adverse Event Reporting 
CC
I