VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
Conditions: Pediatric Safety and Effectiveness
Sponsor: Pfizer

Vfend Special Investigation 
- Investigation For Treatment of Invasive Fungal Infections in Pediatric Patients -
NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Vfend
A1501100   NON-INTERVENTIONAL STUDY PROTOCOL 
Final, 12 May 2015

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STUDY INFORMATION
Title
Special Investigation of Vfend
- Investigation for Treatment of Invasive Fungal 
Infections in Pediatric Patients -
Protocol ID
A1501100
Protocol version identifier
Ver. 1.0
Date of last version of protocol
N/A
Active substance
Voriconazole
Medicinal product
Vfend 200 mg for Intravenous Use
Vfend Tablets 50 mg
Vfend Tablets 200 mg
Vfend Dry Syrup 2800 mg
Research question and objectives
This study is intended to assess the following 
items, etc. for the safety and effectiveness of Vfend 
200 mg for Intravenous Use, Vfend Tablets 50 mg, 
Vfend Tablets 200 mg, and Vfend Dry Syrup 2800 
mg (hereinafter referred to as Product) in daily 
clinical practice for invasive fungal infections in 
children and review the necessity for further 
special investigation and post-marketing clinical 
study. 
- Unknown adverse reactions
- Occurrence of adverse reactions under actual 
clinical settings
- Factors considered to affect the safety and 
effectiveness of this product
Author
Post Marketing Study Strategy and Management
PMS Planning and Operation Group 1
PPD

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TABLE OF CONTENTS
1. LIST OF ABBREVIATIONS......................................................................................................4
2. RESPONSIBLE PARTIES..........................................................................................................5
3. AMENDMENTS AND UPDATES.............................................................................................6
4. MILESTONES.............................................................................................................................6
5. RATIONALE AND BACKGROUND........................................................................................6
6. RESEARCH QUESTION AND OBJECTIVES .........................................................................7
6.1. Safety Specifications.......................................................................................................7
7. RESEARCH METHODS ............................................................................................................7
7.1. Study design ....................................................................................................................7
7.2. Setting..............................................................................................................................7
7.2.1. Inclusion criteria .................................................................................................7
7.2.2. Exclusion criteria..............................................................................................10
7.2.3. Sites for this study ............................................................................................10
7.2.4. Planned investigation period.............................................................................10
7.2.5. Study procedure................................................................................................10
7.2.6. Observation period............................................................................................10
7.3. Variables........................................................................................................................10
7.3.1. Background.......................................................................................................11
7.3.2. Targeted drug use record ..................................................................................12
7.3.3. Concomitant therapy.........................................................................................12
7.3.4. Tests..................................................................................................................12
7.3.5. Final diagnosis (name of infection) ..................................................................13
7.3.6. Completion (discontinuation) record................................................................13
7.3.7. Effectiveness evaluation...................................................................................14
7.3.8. Adverse events..................................................................................................14
7.3.9. Major investigation items .................................................................................15
7.4. Data sources ..................................................................................................................16
7.5. Study size ......................................................................................................................16
7.5.1. Planned sample size..........................................................................................16
7.5.2. Rationale for sample size..................................................................................16

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7.6. Data management..........................................................................................................16
7.6.1. Data collection method.....................................................................................16
7.6.2. Patient registration............................................................................................16
7.6.3. Reminders concerning completion, revision, and submission of case 
report form ........................................................................................................17
7.7. Data analysis .................................................................................................................17
7.8. Quality control...............................................................................................................18
7.9. Limitations of the research methods .............................................................................18
7.10. Other aspects ...............................................................................................................18
8. PROTECTION OF HUMAN SUBJECTS ................................................................................19
8.1. Patient Information and Consent...................................................................................19
8.2. Patient withdrawal.........................................................................................................19
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ....................19
8.4. Ethical Conduct of the Study ........................................................................................19
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS .......................................................................................................................19
9.1. REQUIREMENTS........................................................................................................19
9.2. Reporting period............................................................................................................20
9.3. Causality assessment.....................................................................................................21
9.4. DEFINITIONS OF SAFETY EVENTS .......................................................................21
9.4.1. Adverse events..................................................................................................21
9.4.2. SAE...................................................................................................................22
9.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours .................23
9.5. Single reference safety document..................................................................................25
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS..............25
11. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION.................................26
12. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON WHO 
WAS CONTRACTED WITH THE OPERATIONS...........................................................26
13. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON THE 
STUDY RESULTS AND CRITERIA FOR DETERMINATION OF THE 
INITIATION ........................................................................................................................26

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14. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
REPORTING OF STUDY IMPLEMENTATION STATUS AND EVALUATION 
OF OBTAINED RESULTS TO THE PMDA .....................................................................26
15. OTHER ASPECTS..................................................................................................................27
16. CONTACT INFORMATION..................................................................................................27
16.1. Contact information for the contents of the study.......................................................27
17. REFERENCES ........................................................................................................................27
18. LIST OF TABLES...................................................................................................................27
19. LIST OF FIGURES .................................................................................................................27
20. LIST OF STAND ALONE DOCUMENTS ............................................................................27
21. ADDITIONAL INFORMATION............................................................................................28
1. LIST OF ABBREVIATIONS
Acronym
Tittle
AE
adverse event
Al-P
Alkaline phosphatase
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
BUN
Blood urea nitrogen
CRP
C-reactive protein
EDP
exposure during pregnancy
GGT
Gamma-glutamyltransferase 
IEC
Independent Ethics Committee 
IRB
institutional review board
NIS
Non interventional study  
SRSD
Single Reference Safety Document

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2. RESPONSIBLE PARTIES
The Good Post marketing Study Practice officer
Principal Investigator(s) of the Protocol
N/A

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3. AMENDMENTS AND UPDATES
N/A
4. MILESTONES
Milestone
Planned date
Start of data collection
Jun 2015
End of data collection
Jun 2018
Final study report
To be decided
5. RATIONALE AND BACKGROUND
Vfend (nonproprietary name: voriconazole) is a new triazole therapeutic agent for invasive fungal infections
developed by Pfizer UK Central Laboratory which has a similar structure as fluconazole.
Vfend selectively acts on fungal cells and demonstrates its antimycotic activity by inhibiting cytochrome 
P450-dependent 14α-demethylase in the ergosterol biosynthesis which is a component of fungal cell 
membranes. 
Vfend 200 mg for Intravenous Use, Vfend Tablets 50 mg, and Vfend Tablets 200 mg were approved as drugs 
indicated for invasive aspergillosis, pulmonary aspergilloma, chronic necrotic pulmonary aspergillosis, 
candidaemia, esophageal candidiasis*, candidal peritonitis, bronchopulmonary candidiasis, cryptococcal 
meningitis, pulmonary cryptococcosis, fusariosis, and scedosporiosis on 11 April 2005.  
Furthermore, since the options for antimycotic agents which can be used for pediatric patients are limited in 
Japan, "the Review Committee on Unapproved or Off-Labeled Drugs with High Medical Need" held in April 
2010 evaluated that the pediatric indication of voriconazole had high medical need and requested the 
development of voriconazole for pediatric use.  The pharmacokinetic study of voriconazole in pediatric 
patients was conducted in Japan and the pediatric indication of voriconazole was approved on 26 September 
2014.  In so doing, since the dosage and administration in children need to be adjusted per weight and the use 
of tablets in younger children is expected to be difficult, the approval of oral dry syrup was also obtained as a 
new dosage form. 
Special Investigation of Vfend - Investigation for Treatment of Invasive Fungal Infections in Pediatric Patients
- (hereinafter referred to as "this study") will be conducted to collect information on occurrence of adverse 
reactions by Vfend 200 mg for Intravenous Use, Vfend Tablets 50 mg, Vfend Tablets 200 mg, and Vfend Dry 
Syrup 2800 mg by type of diseases, etc., quality, effectiveness and safety under the actual clinical settings in 
daily clinical practice for children.  The information collected from this study shall be used to provide proper 
use information and prepare documents for the application of re-examination.
This Study shall be conducted in strict compliance with the "Ordinance concerning Standards for Conducting 
Post-Marketing Study and Studies on Pharmaceutical 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 and Medical Device Act; pertinent to which, data may be publicly posted in MHLW's 

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"Pharmaceuticals and Medical Devices 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, sex, 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 physicians, medical institutions, and other personal information be subject to 
such disclosure, nor will it be posted or disclosed in any form or shape.
* Only for tablets and dry syrup
6. RESEARCH QUESTION AND OBJECTIVES
This study is intended to assess the following items, etc. for the safety and effectiveness of Vfend 200 mg for 
Intravenous Use, Vfend Tablets 50 mg, Vfend Tablets 200 mg, and Vfend Dry Syrup 2800 mg (hereinafter 
referred to as this product) in daily clinical practice for invasive fungal infections in children and review the 
necessity for further special investigation and post-marketing clinical study. 
- Unknown adverse reactions
- Occurrence of adverse reactions under actual clinical settings
- Factors considered to affect the safety and effectiveness of this product
6.1. Safety Specifications
[Important identified risks] Hepatic toxicity, QT prolongation, ventricular tachycardia, ventricular fibrillation, 
arrhythmia, complete atrioventricular block, visual events, phototoxicity, peripheral neuropathy such as 
Guillain-Barre syndrome, renal disorder, hematologic disorder, interstitial pneumonia, cardiac failure, 
consciousness disorder
[Important potential risks] None
[Important missing information] Safety of pediatric use
7. RESEARCH METHODS
7.1. Study design
This study is a prospective multicenter cohort study conducted in patients receiving this product; for which, 
case report forms will be recorded based on data presented in medical records obtained in daily clinical 
practice.
7.2. Setting
Patients under the age of 15 years with severe or intractable fungal infection at the initiation of treatment with 
this product are subject to this study. 
7.2.1. Inclusion criteria
1.
Patients under the age of 15 years at the initiation of treatment with this product 
2.
Patients with invasive fungal infections

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The indications, and dosage and administration of this product are as follows.  The latest package 
insert should be referred to when administering this product. 
[INDICATIONS]
Severe mycosis as follows:
- Invasive aspergillosis, Pulmonary aspergilloma, Chronic necrotic pulmonary aspergillosis.
- Candidemea, Esophageal candidasis*, Candidal peritonitis, Bronchopulmonary candidiasis.
- Cryptococcal meningitis, Pulmonary cryptococcosis.
- Fusariosis.
- Scedosporiosis.                  * Only for tablets and dry syrup
[DOSAGE AND ADMINISTRATION]
<for Intravenous Use>
Adult
Voriconazole is administered by intravenous drip infusion at the 
dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg 
twice daily from day 2 onward.
Children (Aged 2 to <12 and ≥12 
whose body weight is less than 50 
kg)
9 mg/kg as voriconazole twice daily on day 1 and 8 mg/kg twice 
daily from day 2 should be given intravenously. Dose may be 
increased if poorly responded by 1 mg/kg at a time, and dose in 
intolerant patients should be reduced by 1 mg/kg at a time.
Children (Aged ≥12 whose body 
weight is 50 kg or more)
6 mg/kg as voriconazole twice daily on day 1 and 4 mg/kg twice 
daily from day 2 should be given intravenously.
<Tablet>
Adult (body weight ≥40 kg)
A recommended oral dose of voriconazole is 300 mg/dose twice 
daily between meals on day 1, and 150 or 200 mg/dose twice 
daily between meals on day 2 and thereafter. Dose may be 
increased depending on condition of patients or if poorly 
responded; provided that a total daily dosage should not exceed 
400 mg/dose twice daily on day 1 and 300 mg/dose twice daily 
on day 2 and thereafter. 

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Adult (body weight <40 kg)
A recommended oral dose of voriconazole is 150 mg/dose twice 
daily between meals on day 1, and 100 mg/dose twice daily 
between meals on day 2 and thereafter. Dose may be increased 
from day 2 onward depending on condition of patients or if 
poorly responded; provided that a total daily dosage should not 
exceed 150 mg/dose twice daily. 
Children (Aged 2 to <12 and ≥12 
whose body weight is less than 
50 kg)
After the administration of Voriconazole injection, a 
recommended maintenance oral dose of voriconazole following 
injection therapy is 9 mg/kg/dose twice daily between meals. 
Dose may be increased by 1 mg/kg at a time if poorly 
responded, and dose in intolerant patients should be reduced by 
1 mg/kg at a time (unless the dosage was at its maximum 350 
mg, in which case, dose should be reduced by 50 mg at a time). 
A total daily dosage should not exceed 350 mg/dose twice daily.
Children (Aged ≥12 whose body 
weight is 50 kg or more)
After the administration of Voriconazole injection, a 
recommended maintenance oral dose of voriconazole following 
injection therapy is 200 mg/dose twice daily between meals; 
which may be increased up to 300 mg/dose twice daily if poorly 
responded. 
<Dry Syrup>
Adult (body weight ≥40 kg)
A recommended oral dose of voriconazole is 300 mg/dose twice 
daily between meals on day 1, and 150 or 200 mg/dose twice 
daily between meals on day 2 and thereafter. Dose may be 
increased depending on condition of patients or if poorly 
responded; provided that a total daily dosage should not exceed 
400 mg/dose twice daily on day 1 and 300 mg/dose twice daily 
on day 2 and thereafter. 
Adult (body weight <40 kg)
A recommended oral dose of voriconazole is 150 mg/dose twice 
daily between meals on day 1, and 100 mg/dose twice daily 
between meals on day 2 and thereafter. Dose may be increased 
from day 2 onward depending on condition of patients or if 
poorly responded; provided that a total daily dosage should not 
exceed 150 mg/dose twice daily. 
Children (Aged 2 to <12 and ≥12 
whose body weight is less than 
50 kg)
After the administration of Voriconazole injection, a 
recommended maintenance oral dose of voriconazole following 
injection therapy is 9 mg/kg/dose twice daily between meals. 
Dose may be increased by 1 mg/kg at a time if poorly 
responded, and dose in intolerant patients should be reduced by 
1 mg/kg at a time (unless the dosage was at its maximum 
350 mg, in which case, dose should be reduced by 50 mg at a 
time). 
A total daily dosage should not exceed 350 mg/dose twice daily.

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Children (Aged ≥12 whose body 
weight is 50 kg or more)
After the administration of Voriconazole injection, a 
recommended maintenance oral dose of voriconazole following 
injection therapy is 200 mg/dose twice daily between meals; 
which may be increased up to 300 mg/dose twice daily if poorly 
responded. 
7.2.2. Exclusion criteria
Patients who correspond to the following must not be registered to this study. 
- Patients who have been registered to this study before
7.2.3. Sites for this study
Sites with presence of doctors specialized in the target therapeutic area primarily in the following departments, 
at which, the product can be prescribed:
Departments of pediatrics, pediatric hematology, etc.
7.2.4. Planned investigation period
Investigation period: June 2015 to June 2018
Registration period: June 2015 to March 2018
(Registration will be discontinued even before the end of the registration period if the target number of patients 
is reached.)
7.2.5. Study procedure
7.2.5.1. Study methods
This study will be conducted with a central registration system. 
7.2.6. Observation period
The observation period shall start on the day the treatment with this product begins and end on the day the 
treatment is completed; provided that it will be cut off at Week 16 of treatment (Day 112 counting from Day 1 
as the day the treatment begins) if the treatment prolongs. 
7.3. Variables
This study will be conducted in accordance with the following assessment schedule.

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Table 1. Schedule of observation
Timing
Variables
Baseline
Observation 
period
Termination of 
observation period
Background
ID number
●
Sex
●
Age at the time when the treatment of 
the targeted drug is initiated
●
Height/body weight
●
Hospitalization status 
(inpatient/outpatient)
●
Objective of treatment
●
Disease history
●
Presence/absence of fever 
unresponsive to antibacterial agents
●
Prior medications for infection for which 
this product is prescribed
●
Presence/absence of pregnancy
●
Targeted drug use record
●
Therapeutic drugs and concomitant 
medications for careful 
administration/contraindication for infection
●
Laboratory tests
●
Final diagnosis (name of infection)
●
Effectiveness evaluation
●
Completion (discontinuation) record
●
Confirmation of presence/absence of adverse 
events which correspond to major investigation 
items (presence/absence of occurrence of 
hepatic toxicity/visual events)
●
Adverse events
●
  ●：Data items
7.3.1. Background
Input the information at the initiation of this product.  
(1) ID number
(2) Sex
(3) Age (at the time when the targeted drug is initiated)
(4) Height
(5) Body weight
(6) Hospitalization status (inpatient/outpatient)
(7) Objective of treatment (infection for which this product is prescribed)
- Treatment of mycosis/others
- Severity
(8) Disease history (information on diseases other than target diseases)
- Presence/absence and severity of hepatic function disorder, renal impairment

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- Name of disease or syndrome, as well as history or pre-existing disease
(9) Presence/absence of fever unresponsive to antibacterial agents
(10) Prior medications for infection for which this product is prescribed (name of antifungal agent 
administered to the target disease from 2 weeks before treatment of this product until the day before the start 
date of treatment, route of administration, reason for discontinuation)
7.3.1.1. Presence/absence of pregnancy
Input the presence/absence of pregnancy from the start date of treatment until the completion of observation 
period (date of delivery (abortion) or expected date of delivery if the patient is pregnant).
7.3.2. Targeted drug use record
The following will be recorded for the treatment status of this product. 
(1) Dosage form 
(2) Dose
(3) Body weight used for calculation of adjustment of this product
(4) Frequency of dose
(5) Treatment period
7.3.3. Concomitant therapy
7.3.3.1. Therapeutic drugs and concomitant medications for precautions/contraindication for 
infection for which this product is prescribed
The following information will be recorded for therapeutic drugs and concomitant medications for careful 
administration/contraindication for infection for which this product is prescribed from the initiation of 
treatment with this product to the completion date of observation period. 
(1) Drug name (product name)
(2) Route of administration
(2) Treatment period
7.3.4. Tests
7.3.4.1. Mycological test
Input assumed causative fungi used for diagnosis of invasive fungal infections (input for each collected 
material/assumed causative fungi).
(1) Testing material
(2) Testing method
(3) Assumed causative fungi (name of fungi, date of sample collection, fungal volume)
(4) Result of susceptibility test
7.3.4.2. Serological test
Input the results of serological test used for diagnosis of invasive fungal infections. 

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(1) Date of collection of sample used for diagnosis
(2) Testing method (β-D-glucan, D-arabinitol, candida antigen, candida mannan antigen, candida antibody, 
cryptococcus neoformans antigen, cryptococcus antibody, aspergillus antigen, aspergillus antibody etc.)
(3) Cut-off value
(4) Test results
7.3.4.3. Imaging test
Input the results of the imaging test which was conducted by the initiation of treatment with this product and 
used for diagnosis of invasive fungal infections (input for each test site). 
(1) Test site
(2) Test date
(3) Presence/absence of findings suspected of invasive fungal infections
7.3.4.4. Plasma voriconazole concentration
If the plasma concentration of voriconazole was measured, input the test results.
(1) Date and time of blood collection 
(2) Date and time of treatment with this product immediately before blood collection 
(3) Plasma voriconazole concentration
7.3.4.5. Laboratory tests
Input the following test items and test items for adverse events. 
[Observation items] White blood cell count, neutrophil count, platelet count, total bilirubin, AST, ALT, Al-P, 
GGT, CRP, BUN, serum creatinine
7.3.5. Final diagnosis (name of infection)
Diagnose the name of infection from clinical symptoms, results of mycological test, serological test, etc.
Follow the latest guideline for diagnosis and treatment of invasive fungal infections for determination of 
patients with definite diagnosis and suspected diagnosis. 
7.3.6. Completion (discontinuation) record
If the observation is completed or discontinued before the end of the longest observation period (16 weeks), 
the reason should be recorded.
If an adverse event is selected for the reason, the information in details should be recorded in the adverse event 
column.
[Reason for completion]
- Cured (effective)
[Reason for discontinuation]
- Insufficient clinical effectiveness

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- Adverse events
- No revisit
- Hospital transfer
- Other
7.3.7. Effectiveness evaluation
7.3.7.1. Clinical response
The clinical response of this product should be evaluated based on the clinical course excluding the 
mycological response at the end of the observation period. 
If this product is used continuously for more than 16 weeks, the clinical response should be evaluated 
comprehensively at Week 16.
- Effective
- Not effective
- Indeterminate (In this case, the reason should be recorded.)
Reason in the case of indeterminate
- Because the diagnosis is not "invasive fungal infections" or "invasive fungal infections suspected"
- Other
7.3.7.2. Mycological response
The mycological response should be determined at the end of the observation period and the results should be 
recorded. 
- Eradication: The causative fungi detected from the focus before treatment with this product has become 
negative
- Presumed eradication: In the case when the focus improved and the collection of test material became 
impossible
- Decreased: The causative fungi decreased
- No change: There is no change in causative fungi
- Increased: The causative fungi increased (including the case of microbial substitution)
- Indeterminate: In the cases when the follow-up was inadequate, the causative fungi were not detected, or the 
mycological test was "not conducted"
7.3.8. Adverse events
Confirm the status of adverse events from the initiation of treatment with this product to the completion of 
observation period, and record the following information. Upon discovery of an adverse event, the attending 
doctor should take appropriate actions, and promptly report to Pfizer Japan Inc. (hereinafter "Sponsor"), and if 
causal relation with this product cannot be ruled out, the doctor should follow up the event until the adverse 
event or its sequelae are resolved or stabilized at the level acceptable by the attending doctor and Sponsor.
Moreover, a study should be conducted on patients in whom a serious adverse reaction, or an adverse reaction 
not specified in the package insert occurred if it is determined necessary by Sponsor.

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(1)
Presence/absence of adverse event
(2)
Name of adverse event
(3)
Date of occurrence
(4)
Action
(5)
Seriousness
(6)
Outcome
(7)
Causality
[If the adverse event is associated with abnormal change in laboratory values, i.e., laboratory tests, the 
following information should also be recorded.]
(1)
Laboratory parameter
(2)
Site reference value
(3)
Unit
(4)
Date of test
(5)
Results
7.3.9. Major investigation items
The following items will be major investigation items in this study.
(1) Hepatic toxicity
For patients who developed events related to hepatic toxicity including abnormal hepatic function test values, 
assess the occurrence status and the differences in patient background, dose, etc. between patients who can 
continuously receive treatment with this product and patients who must discontinue treatment with this 
product. 
(2) Visual events
Set the presence or absence of visual events as an investigation item.  Assess the occurrence status for patients 
who developed visual events and the differences in patient background, dose, etc. between patients who can 
continuously receive treatment with this product and patients who must discontinue treatment with this 
product. 
7.3.9.1. Confirmation of presence/absence of adverse events that correspond to major investigation
items
7.3.9.1.1. Presence/absence of hepatic toxicity
The presence/absence of hepatic toxicity including hepatitis, jaundice, hepatic failure, coma hepatic, ALT 
(GPT) increased, AST (GOT) increased, and γ-GTP increased should be recorded for target patients in this 
study.  If aggravation or new occurrence of hepatic toxicity is observed, the information in details should be 
recorded in the adverse event column.
7.3.9.1.2. Presence/absence of occurrence of visual events
The presence/absence of aggravation or new occurrence of visual events including photophobia, vision blurred, 
and visual disturbance should be recorded for target patients in this study. If aggravation or new occurrence of 
visual event is observed, the information in details should be recorded in the adverse event column.

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7.4. Data sources 
In this study, the investigators extract the necessary information from the medical record in accordance with 
the protocol.
7.5. Study size
7.5.1. Planned sample size
100 patients
7.5.2. Rationale for sample size
The target sample size was set out to 100 patients who developed hepatic toxicity or visual events which are 
major investigation items for whom differences between patients who can continuously receive this product 
and patients who must discontinue the treatment with this product can be evaluated. 
In the reports of adverse reactions in the clinical study (study A1501096) conducted for Japanese children 
(from 2 years old to under 15 years old), there were 4 patients with hepatic toxicity including abnormal hepatic 
function test values (19.0%) and 9 patients with visual events (42.9%). If the number of patients to be collected 
is set out to be 100, the number of patients from whom these events can be detected at a probability of 95% or 
higher is estimated to be 13 patients and 35 patients respectively.  The 100 patients is the number of patients 
from whom adverse reactions that occur at the frequency of 3% or higher can be detected in at least 1 patient at 
a probability of 95% or higher. 
7.6. Data management
7.6.1. Data collection method
Data for this study shall be collected using a specific case report form provided by Pfizer. Investigator will 
complete promptly after observation period and submit them to the Pfizer.
7.6.2. Patient registration
7.6.2.1. Procedure of patient registration
(1) Registration
The following information regarding registration should be recorded in the registration forms if this product is 
given to patients who meet the following registration criteria; patients should be registered via FAX at the 
registration center until the target number of patients is registered. Patients should be registered via FAX 
within 2 weeks from the initiation of treatment with this product with the start date of treatment as Day 1. 
1) Registration criteria
- Patients under the age of 15 years old at the initiation of treatment with this product
- Patients with invasive fungal infections
2) Registration data

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Patient identification number, sex, age at the initiation of treatment, date on which treatment with this product 
begins, eligibility to registration criteria
(2) Exclusion from the registration
Patients found to not meet the registration criteria after the registration form is received at the registration 
center will be excluded from the registration.
7.6.3. Reminders concerning completion, revision, and submission of case report form
7.6.3.1. Completion
The investigator shall, upon confirming the study items, complete the CRF based on medical charts and other 
medical records such as relevant test results, using an ineffaceable ink such as ballpoint pen.
7.6.3.2. Revision
Upon receiving Sponsor's inquiry on the contents of the CRF (query forms), the investigator will again confirm 
the contents of medical records described earlier, and as required, correct relevant sections and resubmit the 
form.  Corrections in the CRF should be struck out with a double line (=) with a "correction seal" on the 
double line; the double line should be drawn so that the original contents prior to correction are legible.
7.6.3.3. Submission
CRFs should be submitted promptly upon completion in accordance with the procedures set out by Sponsor.
7.7. Data analysis
The details of analysis method on data collected in this study shall be described in the Statistical Analysis Plan 
to be separately prepared.
1) Definition of analysis set
The safety analysis set shall include patients for whom the registration in this study and administration of this 
product have been confirmed.
Two analysis sets, which are clinically-evaluable analysis set and mycological analysis set, shall be defined as 
the effectiveness analysis set.  The clinically-evaluable analysis set includes patients for whom performance of 
clinical response was confirmed among patients in the safety analysis set. The mycological analysis set include 
[Patient Registration Center]
FAX:  0120 - 007 - 233 (Accessible 24 hours a day)

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patients for whom microbiological response was assessed among patients in the clinically-evaluable analysis 
set.
2) Analysis method
(1) Safety analysis
The incidence of adverse reactions shall be calculated for each event.  Also, the factors affecting the 
occurrence of adverse reactions shall be evaluated as necessary.
(2) Effectiveness analysis
The clinical response rate (the number of responders / the number of clinically-evaluable patients excluding 
indeterminate patients) and its 95% confidence interval shall be calculated for the clinically-evaluable analysis 
set.  Also, the eradication rate (the number of patients with mycological eradication + presumed eradication /
the number of patients for mycological analysis excluding indeterminate patients) and its 95% confidence 
interval shall be calculated for the mycological analysis set.
Detailed methodology for summary and statistical analyses of data collected in this study will be documented 
in a Statistical Analysis Plan of this study and maintained by Pfizer. The SAP may modify the plans outlined in 
the protocol; any major modifications of primary endpoint definitions or their analyses would be reflected in a 
protocol amendment.
7.8. Quality control
Pfizer staff in charge of site will explain the contents of the protocol, etc. to the investigator prior to the 
implementation of this study and ask the investigator to prepare a case report form based on medical charts. 
7.9. Limitations of the research methods
The following matters are considered for this study:
1) Since no control group is set in the study, there is a limit to the judgment on whether or not a risk of 
developing adverse events and adverse reactions increases due to the administration of the study drug.
2) The consideration for confounding factors may not be adequate because the background information may 
not be sufficiently obtained.
3) Since this is a study that collects the information described in medical charts, the set data may not be 
collected or there may be missing information.
7.10. Other aspects
N/A

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8. PROTECTION OF HUMAN SUBJECTS
8.1. Patient Information and Consent
All parties will ensure protection of patient personal data and will not include patient names on any sponsor 
forms, reports, publications, or in any other disclosures, except where required by laws. In case of data transfer, 
Pfizer will maintain high standards of confidentiality and protection of patient personal data.
In this study, the information will be collected by transcribing medical chart information described in routine 
medical practice. In doing so, the informed consent will not be used because the information collected from 
medical charts is anonymized and does not contain any information that identifies individual patients.
8.2. Patient withdrawal
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time 
at the discretion of the investigator or Sponsor for safety, behavioral, or administrative reasons. In any 
circumstance, every effort should be made to document outcome, if possible. The investigator should inquire 
about the reason for withdrawal and follow-up with the patient regarding any unresolved adverse events.   
8.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
In this study, the review by the IRB/IEC is not essential.
8.4. Ethical Conduct of the Study
This study is excluded from the patient since it includes the scope of application of the "Good Post-Marketing 
Study Practice" (Ordinance of Ministry of Health, Labour and Welfare No. 171 of December 20, 2004)
9. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS
The handling of each event in the case where the investigator becomes aware of any event concerning the 
safety information should be prescribed as follows:
For an event that needs to be reported to the sponsor within 24 hours, the investigator must report it using the 
designated "Non Interventional study AE Report Form (hereinafter referred to as "NIS AE Report Form")
At the initiation of study, each staff in charge of each site shall request each investigator to report events that 
need to be reported within 24 hours of discovery, and visit the investigator periodically within the study period 
to request for reporting. 
The NIS AE Report Form will be handled as part of the case report form.
9.1. REQUIREMENTS
The table below summarizes the requirements for recording safety events on the case report form and for 
reporting safety events on the non-interventional study (NIS) adverse event monitoring (AEM) Report Form to 
Pfizer Safety. These requirements should be described for the following 3 types of events.(1) serious adverse 
events (SAEs); (2) non-serious AEs (as applicable); and (3) scenarios involving exposure to a Pfizer product, 
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extravasations, and occupational exposure. These events are defined in the section “Definitions of safety 
events”.  
Safety event
Recorded on the case report 
form 
Reported on the NIS AE 
Report Form to Pfizer Safety 
within 24 hours of awareness
SAE
All
All
Non-serious AE
All
None.
Scenarios involving exposure to a 
Pfizer product, including exposure 
during pregnancy, exposure during 
breast feeding, medication error, 
overdose, misuse, extravasation; lack 
of efficacy; and occupational exposure
All (regardless of whether associated 
with an AE), except occupational 
exposure
All (regardless of whether 
associated with an AE) involving 
exposure to a Pfizer product
For each AE, the investigator must pursue and obtain information adequate both to determine the outcome of 
the adverse event and to assess whether it meets the criteria for classification as a SAE (see section "Serious 
Adverse Events” below)
Safety events must be reported to Pfizer within 24 hours of awareness of the event by the investigator as 
described in the table above. In particular, if the SAE is fatal or life-threatening, notification to Pfizer must be 
made immediately, irrespective of the extent of available event information. This timeframe also applies to 
additional new (follow-up) information on previously forwarded safety event reports. In the rare situation that 
the investigator does not become immediately aware of the occurrence of a safety event, the investigator must 
report the event within 24 hours after learning of it and document the time of his/her first awareness of the 
events.
For those safety events that are considered serious or that are identified in the far right column of the table 
above that are reportable to Pfizer within 24 hours of awareness, the investigator is obligated to pursue and to 
provide any additional information to Pfizer in accordance with this 24-hour timeframe. In addition, an 
investigator may be requested by Pfizer to obtain specific follow-up information in an expedited fashion.  In 
general, this will include a description of the adverse event in sufficient detail to allow for a complete medical 
assessment of the case and independent determination of possible causality. Information relevant to the event, 
such as concomitant medications and illnesses must be provided. In the case of a patient death, a summary of 
available autopsy findings must be submitted as soon as possible to Pfizer or its designated representative.  
9.2. Reporting period 
For each patient, the safety event reporting period begins at the time of the patient's informed consent, which is 
obtained prior to the patient's registration in the study, and lasts through the end of the observation period of 
the study; a report must be submitted to Pfizer Safety (or its designated representative) for any of the types of 
safety events listed in the table above occurring during this period. If a patient was administered a drug under 
study on the last day of the observation period, then the reporting period should be extended for 28 calendar 
days following the end of observation.
If the investigator becomes aware of a SAE occurring at any time after completion of the study and s/he 
considers the serious AE to be related to a Pfizer product, the SAE also must be reported to Pfizer Safety.  

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9.3. Causality assessment
The investigator is required to assess and record the causal relationship. For all AEs, sufficient information 
should be obtained by the investigator to determine the causality of each adverse event. For AEs with a causal 
relationship to a Pfizer product, follow-up by the investigator is required until the event and/or its sequelae 
resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.  
An investigator's causality assessment is the determination of whether there exists a reasonable possibility that 
a Pfizer product caused or contributed to an adverse event. If the investigator's final determination of causality 
is “unknown” and s/he cannot determine whether a Pfizer product caused the event, the safety event must be 
reported within 24 hours.  
If the investigator cannot determine the etiology of the event but s/he determines that Anaemetro did not cause 
the event, this should be clearly documented on the case report form and the NIS AEM Report Form.  
9.4. DEFINITIONS OF SAFETY EVENTS
9.4.1. Adverse events
An AE is any untoward medical occurrence in a patient administered a medicinal product. The event 
need not necessarily have a causal relationship with the product treatment or usage. Examples of adverse 
events include but are not limited to:  
 Abnormal test findings (see below for circumstances in which an abnormal test finding constitutes an 
adverse event);
 Clinically significant symptoms and signs;
 Changes in physical examination findings;
 Hypersensitivity;
 Progression/worsening of underlying disease;
 Lack of efficacy;
 Drug abuse;
 Drug dependency.
Additionally, for medicinal products, they may include the signs or symptoms resulting from:
 Drug overdose;
 Drug withdrawal;
 Drug misuse; 
 Off-label use; 
 Drug interactions;
 Extravasation;
 Exposure during pregnancy;
 Exposure during breast feeding;
 Medication error;
 Occupational exposure.
Abnormal test findings
The criteria for determining whether an abnormal objective test finding should be reported as an adverse event 
are as follows: 

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Test result is associated with accompanying symptoms, and/or
Test result requires additional diagnostic testing or medical/surgical intervention, and/or
Test result leads to a change in study dosing or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy, and/or
Test result is considered to be an adverse event by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an 
adverse event. Any abnormal test result that is determined to be an error does not require reporting as an 
adverse event.
9.4.2. SAE
A serious adverse event is any untoward medical occurrence in a patient administered a medicinal or 
nutritional product (including pediatric formulas) at any dose or using a medical device that:
Results in death;
Is life-threatening;
Requires inpatient hospitalization or prolongation of hospitalization (see below for circumstances that 
do not constitute adverse events);
Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct 
normal life functions);
Results in congenital anomaly/birth defect.
Medical and scientific judgment is exercised in determining whether an event is an important medical event. 
An important medical event may not be immediately life-threatening and/or result in death or hospitalization. 
However, if it is determined that the event may jeopardize the patient or may require intervention to prevent 
one of the other outcomes listed in the definition above, the important medical event should be reported as 
serious.
Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; 
blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or
drug abuse.
Additionally, any suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-
pathogenic, is considered serious. The event may be suspected from clinical symptoms or laboratory findings 
indicating an infection in a patient exposed to a Pfizer product. The terms “suspected transmission” and 
“transmission” are considered synonymous. These cases are considered unexpected and handled as serious 
expedited cases by PV personnel. Such cases are also considered for reporting as product defects, if 
appropriate.
Hospitalization
Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or equivalent 
healthcare facility or any prolongation to an existing admission. Admission also includes transfer within 
the hospital to an acute/intensive care unit (e.g., from the psychiatric wing to a medical floor, medical 
floor to a coronary care unit, neurological floor to a tuberculosis unit). An emergency room visit does not 
necessarily constitute a hospitalization; however, an event leading to an emergency room visit should be 
assessed for medical importance. 
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable. For example, 
the following reports of hospitalization without a medical AE are not to be reported. 

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 Social admission (e.g., patient has no place to sleep)
 Administrative admission (e.g., for yearly exam)
 Optional admission not associated with a precipitating medical AE (e.g., for elective cosmetic 
surgery)
 Hospitalization for observation without a medical AE
 Admission for treatment of a pre-existing condition not associated with the development of a new AE 
or with a worsening of the pre-existing condition (e.g., for work-up of persistent pre-treatment lab 
abnormality)
 Protocol-specified admission during clinical study (e.g., for a procedure required by the study 
protocol)
9.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours 
Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication error, overdose, 
misuse, extravasation, lack of efficacy, and occupational exposure are described below.
Exposure during pregnancy;
Exposure during pregnancy; An exposure during pregnancy (EDP) occurs if:
1. A female becomes, or is found to be, pregnant either while receiving or having been exposed to (e.g., 
environmental) Anaemetro, or the female becomes, or is found to be, pregnant after discontinuing and/or being 
exposed to Anaemetro (maternal exposure). 
An example of environmental exposure would be a case involving direct contact with a Pfizer product in a 
pregnant woman (e.g., a nurse reports that she is pregnant and has been exposed to chemotherapeutic products).
2. A male has been exposed, either due to treatment or environmental exposure to a Pfizer product prior to or 
around the time of conception and/or is exposed during the partner pregnancy (paternal exposure). 
As a general rule, prospective and retrospective exposures during pregnancy reports from any source are 
reportable irrespective of the presence of an associated AE and the procedures for SAE reporting should be 
followed.
If a study participant or study participant's partner becomes, or is found to be, pregnant during the study 
participant's treatment with a Pfizer product, this information must be submitted to Pfizer, irrespective of 
whether an adverse event has occurred, must be submitted using the NIS AEM Report Form and the EDP 
Supplemental Form. 
In addition, the information regarding environmental exposure to a Pfizer product, in a pregnant woman (e.g., a 
subject reports that she is pregnant and has been exposed to a cytotoxic product by inhalation or spillage) must 
be submitted using the NIS AEM Report Form and the EDP supplemental form. This must be done 
irrespective of whether an AE has occurred.  
Information submitted should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy, in addition, follow-up is conducted to 
obtain information on EDP outcome for all EDP reports with pregnancy outcome unknown. A pregnancy is 
followed until completion or until pregnancy termination (e.g., induced abortion) and Pfizer is notified of the 
outcome. This information is provided as a follow up to the initial EDP report. In the case of a live birth, the 

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structural integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural integrity of the 
terminated fetus should be assessed by gross visual inspection (unless pre-procedure test findings are 
conclusive for a congenital anomaly and the findings are reported).
If the outcome of the pregnancy meets the criteria for an SAE (e.g., ectopic pregnancy, spontaneous abortion, 
intrauterine fetal demise, neonatal death, or congenital anomaly [in a live born, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death]), the procedures for reporting SAEs should be followed.
Additional information about pregnancy outcomes that are reported as SAEs follows: 
Spontaneous abortion includes miscarriage and missed abortion;
Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality, as 
SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the 
infant death as related or possibly related to exposure to investigational product
Additional information regarding the exposure during pregnancy may be requested. Further follow-up of birth 
outcomes will be handled on a case-by-case basis (e.g., follow-up on preterm infants to identify developmental 
delays).  
In the case of paternal exposure, the study participant will be provided with the Pregnant Partner Release of 
Information Form to deliver to his partner. It must be documented that the study participant was given this 
letter to provide to his partner.
Exposure during breast feeding;
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of an associated AE. 
An exposure during breastfeeding report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (e.g., vitamins) is administered in accord with authorized use. However, if the infant 
experiences an AE associated with such a drug's administration, the AE is reported together with the exposure 
during breastfeeding.
Medication error;
A medication error is any unintentional error in the prescribing, dispensing or administration of a 
medicinal product that may cause or lead to inappropriate medication use or patient harm while in the 
control of the health care professional, patient, or consumer. Such events may be related to professional 
practice, health care products, procedures, and systems including: prescribing; order communication; 
product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; 
education; monitoring; and use.
Medication errors include:
 Near misses, involving or not involving a patient directly (e.g., inadvertent/erroneous administration, 
which is the accidental use of a product outside of labeling or prescription on the part of the healthcare 
provider or the patient/consumer);
 Confusion with regard to invented name (e.g., trade name, brand name).
The investigator must submit the following medication errors to Pfizer, irrespective of the presence of an 
associated AE/SAE :

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 Medication errors involving patient exposure to the product, whether or not the medication error is 
accompanied by an AE.
 Medication errors that do not involve a patient directly (e.g., potential medication errors or near 
misses). When a medication error does not involve patient exposure to the product the following 
minimum criteria constitute a medication error report:
 An identifiable reporter;
 A suspect product;
 The event medication error.
Overdose, Misuse, Extravasation
Reports of overdose, misuse, and extravasations associated with the use of a Pfizer product are reported to 
Pfizer by the investigator, irrespective of the presence of an associated AE/SAE. 
Lack of efficacy;
Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the investigator, irrespective of the 
presence of an associated AE/SAE or the indication for use of the Pfizer product.
Occupational exposure.
Reports of occupational exposure to a Pfizer product are reported to Pfizer by the investigator, irrespective of 
the presence of an associated AE/SAE.
9.5. Single reference safety document
A Single Reference Safety Document (SRSD) refers to a document that contains the information on the known 
safety profile. The package insert of this product will be the SRSD in this study. Pfizer Japan Inc. will evaluate 
the safety information reported by the investigator during the study period using the SRSD.
The investigator will also prescribe the drug and give the drug administration guidance based on the SRSD.
10. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
The study results may be published during scientific meetings, in research paper, etc. for the purpose of 
providing proper use information, etc.
COMMUNICATION OF ISSUES
In the event of any prohibition or restriction imposed (e.g., clinical hold) by an applicable Competent 
Authority in any area of the world, or if the investigator is aware of any new information which might 
influence the evaluation of the benefits and risks of a Pfizer product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures taken by the 
investigator to protect the study patients against any immediate hazard, and of any serious breaches of this NI 
study protocol that the investigator becomes aware of.

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11. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION
The organizational system in this study is equivalent to that for the operations such as the risk management 
plan and post-marketing study.  The director of the post-marketing study strategy and management will be 
responsible for post-marketing study.
12. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON WHO WAS 
CONTRACTED WITH THE OPERATIONS
1) Subcontractors
(1)Registration center
Company name: EP Pharma Line Co., Ltd.
Address: 3-27-12 Nishi-Ikebukuro, Toshima-ku, Tokyo
(2) Destination of case report and query forms, data management, and statistical analysis
Company name: EPS Corporation
Address: 8F Acropolis TOKYO, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo
2) Scope of subcontract 
Activities concerning registration center, destination of case report and query forms, data management, 
and statistical analysis, except for management activities.
13. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON THE STUDY 
RESULTS AND CRITERIA FOR DETERMINATION OF THE INITIATION
The Drug Risk Management Plan should be reviewed and revised as necessary at each relevant milestone for 
the contents including the following information. 
The necessity to amend the protocol of this study including presence/absence of new safety specifications 
should be discussed. 
The necessity of risk minimization plan including that for new safety specifications should be discussed. 
Amendment of the risk minimization activities for the current safety specification should be discussed.
14. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR REPORTING OF 
STUDY IMPLEMENTATION STATUS AND EVALUATION OF OBTAINED RESULTS TO THE 
PMDA
[Planned milestone]
At the time of Periodic Safety Report
[Rationale]
To comprehensively evaluate the safety information

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15. OTHER ASPECTS
1）Amendment of the protocol
Based on the new knowledge to be obtained according to the progress of this study, the need for amendment of 
the protocol will be examined and the protocol will be amended if necessary.  Also, the need for amendment of 
the protocol will be examined and the protocol will be amended even if the partial change in the dosage and 
administration or indication is approved during the reexamination period (except the case when the 
reexamination period is newly designated), etc.
2）Actions to be taken if any problem or question is observed
In the cases where the onset of any serious and unknown adverse reaction is suggested, a significant increase in 
the frequency of adverse reactions is observed, any problem is found in the effectiveness and safety of the drug 
compared to those prior to the approval, the onset of a different kind of adverse reaction is suggested, etc., the 
amendment of the package insert and implementation of a new special investigation or post-marketing clinical 
study should be considered.
16. CONTACT INFORMATION
16.1. Contact information for the contents of the study
Name
Pfizer Japan Inc. Post Marketing Study Strategy and Management
Address
Shinjuku Bunka Quint Building 3-22-7 Yoyogi Shibuya-ku, Tokyo 151-
8589
E-mail address
VFD-pedPMS@pfizer.com
17. REFERENCES
None.
18. LIST OF TABLES
・Page11.  Table 1.Schedule of observation
19. LIST OF FIGURES
N/A
20. LIST OF STAND ALONE DOCUMENTS
N/A

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21. ADDITIONAL INFORMATION
N/A