A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
Phase: PHASE2
Conditions: HIV-1 Infection
Sponsor: Gilead Sciences

Study Title: 
Sponsor: 
EudraCT No.: 
Protocol ID: 
Gilead Medical 
Monitor: 
CRO Medical 
Monitor: 
Protocol Version/ 
Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Rollover Protocol to Provide Subjects Completing the FTC-203 
Study in South Africa with Continued Access to Emu·icitabine 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, Califomia 94404, USA 
Not applicable 
GS-US-162-0112 
Name: 
Erin Quirk, M.D. 
Telephone: PPD 
Fax: 
PPD 
Not applicable 
Amendment 1: 24 July 2013 
Original: 24 Janua1y 2005 
CONFIDENTIALITY STATEMENT 
The inf01m ation contained in this document, patiicularly unpublished data, is the prope1iy or 
under conu·ol of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
Institutional Review Bom·d or Independent Ethics Committee. The inf01m ation is only to be 
used by you in connection with authorized clinical studies of the investigational dmg 
described in the protocol. You will not disclose any of the inf01m ation to others without 
written authorization from Gilead Sciences, Inc., except to the extent necessmy to obtain 
inf01m ed consent from those persons to whom the dmg may be administered. 

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TABLE OF CONTENTS
TABLE OF CONTENTS .......................................................................................................................................2
LIST OF IN-TEXT TABLES.................................................................................................................................3
PROTOCOL SYNOPSIS .......................................................................................................................................3
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ..............................................................8
1.
INTRODUCTION .........................................................................................................................................9
1.1.
Background.......................................................................................................................................9
1.2.
Rationale for the Current Study ........................................................................................................9
2.
OBJECTIVES..............................................................................................................................................11
3.
STUDY DESIGN ........................................................................................................................................12
3.1.
Treatment Plan and Regimen..........................................................................................................12
4.
SUBJECT POPULATION...........................................................................................................................13
4.1.
Number of Subjects and Subject Selection .....................................................................................13
4.2.
Inclusion Criteria ............................................................................................................................13
4.3.
Exclusion Criteria ...........................................................................................................................14
5.
STUDY DRUGS..........................................................................................................................................15
5.1.
Randomization and Blinding...........................................................................................................15
5.2.
Description and Handling of Emtricitabine ....................................................................................15
5.2.1.
Formulation...................................................................................................................15
5.2.2.
Packaging and Labeling ................................................................................................15
5.2.3.
Storage and Handling....................................................................................................15
5.3.
Dosage and Administration of Emtricitabine..................................................................................16
5.4.
Prior and Concomitant Medications................................................................................................17
6.
STUDY PROCEDURES .............................................................................................................................18
6.1.
Subject Enrollment and Treatment Assignment..............................................................................18
6.2.
Study Assessments..........................................................................................................................18
6.2.1.
End-of-Study Visit (FTC-203)/Baseline Visit (GS-US-162-0112)...............................18
6.2.2.
Clinic Visits...................................................................................................................19
6.3.
Assessments for Premature Discontinuation From Study...............................................................20
6.4.
Criteria for Suspension of Study Drug............................................................................................20
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT........................................................................22
7.1.
Adverse Events ...............................................................................................................................22
7.2.
Assessment of Adverse Events .......................................................................................................22
7.3.
Serious Adverse Events ..................................................................................................................23
7.4.
Special Situations Reports ..............................................................................................................24
7.4.1.
Definitions of Special Situations...................................................................................24
7.4.2.
Instructions for Reporting Special Situations................................................................25
7.5.
Serious Adverse Event Reporting Requirements ............................................................................26
7.5.1.
All Serious Adverse Events...........................................................................................26
7.5.2.
Investigator Reporting Requirements for SAEs............................................................27
7.5.3.
Post Study Reporting Requirements..............................................................................27
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events 
or Serious Adverse Events ..............................................................................................................27
7.7.
Toxicity Management .....................................................................................................................28
7.8.
Major Toxicities of Emtricitabine...................................................................................................28

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7.8.1.
Skin Discoloration.........................................................................................................28
7.9.
Contraception Requirements for Males and Females of Childbearing Potential.............................29
7.9.1.
Definition of Female of Childbearing Potential ............................................................29
7.9.2.
Contraception Requirements.........................................................................................29
7.9.3.
Additional Requirements for Male Subjects .................................................................30
7.9.4.
Risks for Women of Childbearing Potential or During Pregnancy ...............................31
8.
STATISTICAL CONSIDERATIONS.........................................................................................................32
9.
RESPONSIBILITIES ..................................................................................................................................33
9.1.
Investigator Responsibilities ...........................................................................................................33
9.1.1.
Good Clinical Practice ..................................................................................................33
9.1.2.
Independent Ethics Committee Approval .....................................................................33
9.1.3.
Informed Consent..........................................................................................................33
9.1.4.
Confidentiality ..............................................................................................................33
9.1.5.
Study Files and Retention of Records...........................................................................34
9.1.6.
Case Report Forms........................................................................................................35
9.1.7.
Drug Accountability......................................................................................................35
9.1.8.
Inspections ....................................................................................................................35
9.1.9.
Protocol Compliance.....................................................................................................35
9.2.
Sponsor Responsibilities.................................................................................................................36
9.2.1.
Protocol Modifications..................................................................................................36
9.2.2.
Study Report and Publications ......................................................................................36
9.3.
Joint Investigator/Sponsor Responsibilities ....................................................................................36
9.3.1.
Access to Information for Monitoring...........................................................................36
9.3.2.
Access to Information for Auditing or Inspections .......................................................37
9.3.3.
Study Discontinuation...................................................................................................37
10.
REFERENCES ............................................................................................................................................38
11.
APPENDICES .............................................................................................................................................39
Appendix 1.
Investigator Signature Page...........................................................................................40
Appendix 2.
Emtricitabine (Emtriva) Dose Tables..........................................................................41
Appendix 3.
Study Procedures Table.................................................................................................43
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities..........................................................................................45
LIST OF IN-TEXT TABLES
Table 7-1.
Protocol-Recommended Contraceptive Methods..........................................................30

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Amendment 1 
Title of Study: 
EudraCT 
Number: 
Study Centers: 
Objective: 
Study Design: 
CONFIDENTIAL 
PROTOCOL SYNOPSIS 
Gilead Sciences, Inc. 
333 Lakeside Dr, 
Foster City, CA 94404, USA 
A Rollover Protocol to Provide Subjects Completing the FTC-203 
Study in South Africa with Continued Access to Emu·icitabine 
Not applicable 
This study will be conducted at two study centers: 
PPD 
PPD 
Pt;rinatal HIV Research Unit 
Infectious Diseases Clinical Trial 
Unit 
PPD 
The objectives of this study are: 
• 
To provide cunent FTC-203 study pruticipants in South Africa with 
continued access to the study dmg, emu·icitabine, following 
completion of the FTC-203 study. 
• 
To collect long-tenn safety inf01mation in subjects receiving 
emu·icitabine in combination with other antireu·oviral agents. 
The fomth amendment to the FTC-203 protocol allowed subjects 
meeting predete1mined virologic criteria to continue receiving 
emtricitabine beyond the Week 96 Visit until such time as emti1citabine 
is available via mru·ket disu·ibution in the subject's cmmtly of residence. 
With the last subject completing the original 48-week study dmation in 
May 2004, the decision has been made to close the FTC-203 study after 
the last subject completes the Week 96 visit. In those counu·ies where 
regulat01y approval for market disu·ibution of emu·icitabine has yet to 
be sought and/or is pending, altemative means to provide FTC-203 
study pruticipants with continued access to emu·icitabine ru·e being 
implemented. This open-label, non-randomized rollover protocol will 
provide those FTC-203 study pa1ticipants enrolled at the two study 
centers in South Africa with continued access to the study dmg, 
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emtricitabine, following the completion of the FTC-203 study.  Each 
eligible subject electing to participate in the rollover protocol will 
continue to receive emtricitabine, to be administered in combination 
with other antiretroviral medications, for as long as (s)he continues to 
meet the aforementioned virologic criteria.  Emtricitabine will be 
provided by the Sponsor; all other antiretroviral medications will be 
sourced through a local commercial supplier and funded through a 
treatment grant program.
Number of 
Subjects 
Planned:
Enrollment will be limited to current FTC-203 study participants 
enrolled at the two study centers in South Africa.  A total of 59 subjects 
were enrolled between the two study centers, representing the 
maximum possible enrollment in this protocol.
Target 
Population:
HIV-1 infected pediatric subjects currently enrolled in FTC-203 at the 
two study centers in South Africa who are eligible and who wish to
continue to receive the study drug, emtricitabine, beyond completion of 
the FTC-203 study.  Subjects must have completed at least 96 weeks on 
the FTC-203 study and will be required to complete the End-of-Study 
Visit for FTC-203 prior to transitioning into the rollover protocol.
Duration of 
Treatment:
Subjects participating in the rollover protocol will receive the study 
drug, emtricitabine, for as long as they continue to meet the following 
virologic criteria:

they have a plasma HIV-1 RNA viral load of 400 copies/mL, or

if the subject’s plasma HIV-1 RNA viral load is > 400 copies/mL, 
their viral load is < 1.0 log10 above the nadir recorded after Week 8 
of the FTC-203 study and there is reliable genotypic evidence 
showing a lack of resistance to emtricitabine,
and until either: (1) the subject chooses to discontinue treatment of 
emtricitabine and withdraw from the rollover protocol; (2) the subject 
experiences a toxicity that necessitates the permanent discontinuation 
of emtricitabine, or (3) emtricitabine is approved for market distribution 
in the subject’s country of residence.
Diagnosis and 
Main 
Eligibility 
Criteria:
Current FTC-203 study participants are eligible to participate in this 
rollover protocol if (1) they complete all End-of-Study Visit procedures 
for the FTC-203 study, and (2) either (a) they have a plasma HIV-1 
RNA viral load of 400 copies/mL at the End-of-Study Visit, or (b) if 
the subject’s plasma HIV-1 RNA viral load is > 400 copies/mL at the 
End-of-Study Visit, their viral load is < 1.0 log10 above the nadir 
recorded after Week 8 of the FTC-203 study and there is reliable 
genotypic evidence showing a lack of resistance to emtricitabine.

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Study 
Procedures/
Frequency:
During the rollover protocol, the Investigator will manage each subject
according to current “standard of care” practices at his (or her) 
institution, with the subject returning to the clinic approximately every 
12 weeks for study visits (i.e., four visits per year).  The Investigator 
may choose to have the subject return to the clinic on a more frequent 
basis as part of their standard of care, but these visits will be outside of 
the protocol-defined visit schedule.
Data collection during the rollover protocol for safety purposes will be 
limited to the reporting of adverse events (AEs) that (1) meet the 
criteria for a serious adverse event (SAE), (2) result in permanent 
discontinuation of the study drug, emtricitabine, and/or (3) are 
associated with skin discoloration (hyperpigmentation).  Information 
relating to the dispensing and accountability of the study drug will also 
be recorded.
Non-serious AEs that do not result in the discontinuation of 
emtricitabine and/or are not associated with skin discoloration 
(hyperpigmentation), the results of routine clinical laboratory testing 
(hematology, clinical chemistry and urinalysis), immunological data 
(absolute and percent CD4+), pregnancy test results, and physical 
examination findings collected in the FTC-203 study will no longer be 
collected or recorded in the case report form (CRF), nor will the 
findings of any assessments done according to current standard of care 
practices be recorded in the CRF.
HIV-1 RNA viral load levels will be assessed at each clinic visit to 
ensure continued subject eligibility, regarding the virologic criteria; 
however, these data will not be recorded in the CRF.  Genotypic 
analysis may be required to determine whether a subject is eligible to 
participate in the rollover protocol at the End-of-Study Visit for 
FTC-203 or, after they have entered the rollover protocol, to determine 
whether the subject has failed the criteria for virologic success and 
should permanently discontinue treatment with the study drug, 
emtricitabine. 
Test Product, 
Dose, and Mode 
of 
Administration:
Emtricitabine: 6 mg/kg once daily (QD), up to a maximum of 200 mg 
QD using the capsule formulation or up to a maximum of 240 mg QD 
using the oral solution formulation, with both formulations administered 
orally.  Other antiretroviral medications will be administered at the dose 
or doses recommended by the manufacturer in the relevant 
product/package insert for the treatment of pediatric patients.

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Reference 
Therapy, Dose, 
and Mode of 
Administration:
Not applicable.
Criteria for 
Evaluation:
Safety:
SAEs, AEs leading to discontinuation of the study drug, emtricitabine, 
regardless of seriousness/severity and AEs associated with skin 
discoloration (hyperpigmentation) will be recorded in the CRF.
Efficacy:
Not applicable.
PK:
Not applicable.
Statistical 
Methods:
No statistical analyses are planned.  Data listings will be generated for 
all data collected in the clinical database.  Listings will include subject 
enrollment/disposition, demographics (from the FTC-203 clinical 
database), SAEs, AEs leading to permanent discontinuation of study 
drug, emtricitabine, AEs associated with skin discoloration 
(hyperpigmentation), and study drug dispensing/accountability.  Tabular 
summaries will be prepared.
This study is being performed in compliance with the guideline of Good Clinical Practice 
(GCP) and all essential documents are being archived as required by regulatory authorities.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
AE
adverse event (or experience)
ART
antiretroviral therapy
-HCG
beta human chorionic gonadotropin
CFR
US Code of Federal Regulations
CRF
Case Report Form
DAIDS
Division of AIDS, NIAID
EU
European Union
EUDRA(CT)
European Union Drug Regulatory Authorities (Clinical Trials)
FDA
US Food and Drug Administration
FTC
emtricitabine (Emtriva)
GCP
Good Clinical Practice (Guidelines)
GSI
Gilead Sciences, Inc.
HIV
human immunodeficiency virus
HIV-1
human immunodeficiency virus type 1
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IND
Investigational New Drug (Application)
NIAID
US National Institute of Allergy and Infectious Diseases
NRTI
nucleoside reverse transcriptase inhibitor
QD
quaque die (once daily)
RNA
ribonucleic acid
SAE
serious adverse event (or experience)
US(A)
United States (of America)

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1.
INTRODUCTION
1.1.
Background
Emtricitabine (5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-[1,3]-oxathiolan-5-yl] cytosine, FTC) 
is a nucleoside reverse transcriptase inhibitor (NRTI) that has demonstrated potent and 
selective inhibition of the human immunodeficiency virus (HIV).  In HIV-infected adults, 
emtricitabine is administered as a 200 mg once daily (QD) dose concurrently with other 
antiretroviral drugs.  The 200 mg Emtriva(emtricitabine) Capsule formulation was 
approved by the US Food and Drug Administration (FDA) for marketing on 2 July 2003.  In 
the European Union (EU), marketing authorization was granted for both the 200 mg 
Emtriva(emtricitabine) Capsule formulation and a 10 mg/mL Emtriva(emtricitabine) Oral 
Solution formulation on 24 October 2003, with indications for the treatment of HIV infection 
concurrently with other antiretroviral drugs in both adult and pediatric patients.  In pediatric 
patients, the recommended dose of emtricitabine is 6 mg/kg QD, up to a maximum of 200 mg 
QD when administered using the capsule formulation (for children weighing > 33 kg) or up 
to a maximum of 240 mg when administered using the oral solution formulation.  
Gilead Sciences, Inc. (GSI) continues to pursue applications for regulatory approval of 
emtricitabine in selected countries outside of the USA and EU.
1.2.
Rationale for the Current Study
Study FTC-203 is an ongoing multi-center, open-label, non-randomized Phase 2 clinical 
study to evaluate the safety, antiretroviral activity and pharmacokinetics of emtricitabine in 
combination with other antiretroviral agents in pediatric HIV-infected patients.  The study 
was designed to enroll approximately 60 to 120 HIV-1 infected, ART-naïve and 
ART-experienced, male and female pediatric patients between the ages of 3 months and 
17 years, inclusive.  A total of 116 patients with confirmed HIV-1 infection were actually 
enrolled in this study between 12 study centers located in the USA (8 centers), South Africa 
(2 centers), Mexico (1 center) and Panama (1 center).  Twenty-two patients were enrolled in 
the USA, with 59 patients enrolled in South Africa, 6 patients enrolled in Mexico and 
29 patients enrolled in Panama.
According to the original protocol, all patients were to be treated for an initial period of at 
least 48 weeks, providing (s)he did not meet the study drug discontinuation criteria.  With the 
implementation of the third protocol amendment, the study duration was formally extended 
to 96 weeks, thereby allowing patients to continue receiving treatment for an additional 
48 weeks providing they met and continued to meet one of the following virologic criteria:

the patient’s plasma HIV-1 RNA level was 400 copies/mL
OR

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
if the patient’s plasma HIV-1 RNA level was > 400 copies/mL, the patient’s plasma 
HIV-1 RNA level was < 1.0 log10 above the nadir recorded after Week 8 and there was 
reliable genotypic evidence showing a lack of viral resistance to emtricitabine.
With the implementation of the fourth protocol amendment, patients who continued to meet 
either of the above virologic criteria were allowed to continue receiving emtricitabine beyond 
Week 96 until such time as the drug is available via market distribution in the patient’s 
country of residence.  With the last patient completing the original 48-week study duration in 
May 2004, the decision has been made to close the FTC-203 study after the last patient 
completes his (or her) Week 96 visit.  In those countries where regulatory approval for 
market distribution of emtricitabine has yet to be sought and/or is pending, alternative means 
to continue to provide FTC-203 study participants with access emtricitabine are being 
implemented.  The purpose of the current protocol is to allow those patients in South Africa 
who are current FTC-203 study participants to continue to receive emtricitabine (either 
capsule or oral solution formulation) beyond completion of the FTC-203 study.  Each eligible 
subject electing to participate in the rollover protocol will continue to receive emtricitabine, 
to be administered in combination with other antiretroviral medications, for as long as (s)he 
continues to meet the aforementioned virologic criteria.

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2.
OBJECTIVES
The objectives of this study are:

To provide current FTC-203 study participants in South Africa with continued access to 
the study drug, emtricitabine, following completion of the FTC-203 study in both 
countries.

To collect long-term safety information in subjects receiving emtricitabine in 
combination with other antiretroviral agents.

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3.
STUDY DESIGN
3.1.
Treatment Plan and Regimen
This is an open-label, non-randomized rollover protocol that will provide current FTC-203 
study participants enrolled at the two study centers in South Africa with continued access to 
the study drug, emtricitabine, following completion of the FTC-203 study.  A total of 
59 subjects were enrolled in South Africa between the two study centers, representing the 
maximum possible enrollment in this protocol.
Each eligible subject electing to participate in the rollover protocol will continue to receive 
emtricitabine, in combination with other antiretroviral medications, for as long as they 
continue to meet the following virologic criteria:

they have a plasma HIV-1 RNA viral load of 400 copies/mL, or

if the subject’s plasma HIV-1 RNA viral load is > 400 copies/mL, their viral load is 
< 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is 
reliable genotypic evidence showing a lack of resistance to emtricitabine,
and until either: (1) the subject chooses to discontinue treatment of emtricitabine and 
withdraw from the rollover protocol; (2) the subject experiences a toxicity that necessitates 
the permanent discontinuation of emtricitabine, or (3) emtricitabine is approved for market 
distribution in the subject’s country of residence.
Subjects must complete at least 96 weeks on the FTC-203 study and will be required to 
complete the End-of-Study Visit for FTC-203 before transitioning into the rollover protocol.  
During the rollover protocol, the Investigator will manage each subject according to current 
“standard of care” practices at his (or her) institution, with the subject returning to the clinic 
approximately every 12 weeks for study visits (i.e., four times per year).  The Investigator 
may choose to have the subject return to the clinic on a more frequent basis as part of their 
standard of care, but these visits will be outside of the protocol-defined visit schedule.
Data collection during the rollover protocol for safety purposes will be limited to the 
reporting of adverse events (AEs) that (1) meet the criteria for a serious adverse event (SAE), 
(2) result in permanent discontinuation of the study drug, emtricitabine, and/or (3) are 
associated with skin discoloration (hyperpigmentation) (see Section 7.8.1).  Information 
relating to the dispensing and accountability of the study drug will also be recorded.

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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
Enrollment will be limited to current FTC-203 study participants enrolled at the two study 
centers in South Africa.  A total of 59 subjects were enrolled between the two study centers, 
representing the maximum possible enrollment in this protocol.  Prospective subjects must 
complete at least 96 weeks on the FTC-203 study and will be required to complete the 
End-of-Study Visit for FTC-203 before transitioning into the rollover protocol.  Prospective 
subjects must also meet the inclusion criteria described in Section 4.2 below.
4.2.
Inclusion Criteria
To participate in the rollover protocol, each subject must meet all of the following inclusion 
criteria:

Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks 
on study) for the FTC-203 study.

Complete all End-of-Study Visit procedures for the FTC-203 study.

Either (a) have a plasma HIV-1 RNA viral load of 400 copies/mL at the End-of-Study 
Visit for the FTC-203 study, or (b) if the subject’s plasma HIV-1 RNA viral load at the 
End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0 log10
above the nadir recorded after Week 8 of the FTC-203 study and there is reliable 
genotypic evidence showing a lack of resistance to emtricitabine.

A parent or other legal guardian has provided written informed consent to the subject 
participating in the rollover protocol.  As applicable, based on the subject’s age and 
normal institution practice, the subject should additionally provide their written informed 
consent or assent to participate in the rollover protocol.

If a female of childbearing potential has a negative serum beta-human chorionic 
gonadotropin (-HCG) test at the End-of-Study Visit for the FTC-203 study.

If sexually active (male and female) and/or of childbearing potential, be willing to use an 
effective method of contraception while enrolled in the study and for a period of at least
1 month after the last dose of emtricitabine. See Section 7.9.4 for more information on 
contraception and pregnancy.

Male subjects must refrain from sperm donation from Day -1 through completion of the 
study and continuing for at least 90 days from the date of last dose of study drug.

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
Have no medical condition or any other set of circumstances, which, in the opinion of the 
Investigator or Sponsor, means that it would not be in the best interests of the subject to
participate in the rollover protocol and/or continue treatment with emtricitabine.
4.3.
Exclusion Criteria
Not applicable.

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5.
STUDY DRUGS
Each eligible subject electing to participate in the rollover protocol will continue to receive 
emtricitabine, in combination with other antiretroviral medications.  Emtricitabine will be 
provided by the Sponsor; all other antiretroviral medications will be sourced through a local 
commercial supplier and funded through a treatment grant program.
5.1.
Randomization and Blinding
Not applicable; this is an open-label study.
5.2.
Description and Handling of Emtricitabine
5.2.1.
Formulation
Emtricitabine will be provided as a flavored, sweetened oral solution (10 mg/mL) and a solid 
medication, as 200 mg gelatin capsules.
Generic Name:
Emtricitabine (USAN-approved)
CAS Name:
(2R-cis)-4-amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxanthiolan-5-yl]-2 (1H)-
pyrimidinone
CAS Number:
143491-57-0
IUPAC Name:
(2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
Other Names:
(-)-2’,3’-dideoxy-5-fluoro-3’-thiacytidine
FTC
Dosage Forms:
Oral solution; Capsule
Strength:
10 mg/mL; 200 mg
Additional information on the emtricitabine formulations can be found in the Investigator’s 
Brochure (See the most recent edition of the Emtricitabine (FTC) Brochure).
5.2.2.
Packaging and Labeling
Emtricitabine will be supplied by GSI from a central drug storage facility.  Drug labels will 
reflect all necessary information required by the relevant regulatory authority(ies) and/or 
local laws governing the packaging and labeling of investigational medications.
5.2.3.
Storage and Handling
Qualified personnel at each study center will dispense emtricitabine to subjects at each clinic 
visit.  The Investigator (or designee) will need to monitor the supply of emtricitabine for each 
subject and order the drug as needed from the central drug storage facility.  Once received by 

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the study center, emtricitabine must be accounted for in the drug accountability log provided 
by the Sponsor (or equivalent documentation).  The log will include the date the medication 
is received at the study center, the date drug is dispensed to a subject, and the date any extra 
medication or empty bottles are returned to the study center by the subject.  All unused 
emtricitabine must be returned to the Sponsor’s designee at the end of the study.
Emtricitabine oral solution should be refrigerated at 2 to 8C (36 to 46F) until dispensed.  
Once dispensed to the subject, emtricitabine oral solution may be kept at room temperature 
up to 25°C (77°F) for 90 days.  Emtricitabine capsules should be stored at 15 to 30C 
(59 to 86F).  The storage conditions for emtricitabine may change during this protocol.  If 
this occurs, revised instructions regarding the storage of emtricitabine will be provided.
Additional information regarding the storage and handling of emtricitabine capsules and oral 
solution can be found in the emtricitabine Investigator’s Brochure (See most recent edition of 
the Emtricitabine (FTC) Brochure).
5.3.
Dosage and Administration of Emtricitabine
The exact volume of solution/number of capsules of emtricitabine to be administered will be 
based on body weight at a dose of 6 mg/kg QD, with a maximum dose of 200 mg QD using 
the capsule formulation (for children weighing 33 kg) or a maximum dose of up to 240 mg 
QD using the oral solution formulation.  The 6 mg/kg QD dose has been shown to achieve 
steady-state emtricitabine plasma concentration comparable to that observed in adults given 
the recommended 200 mg of emtricitabine QD using capsules {7438}.
For the purposes of determining the dose of emtricitabine to be administered, each subject’s 
body weight (in kg) will be measured at each study visit (such data will not be recorded in 
the CRF).  Older subjects should be weighed with only a minimum amount of clothing in 
place.  Infants and toddlers using diapers should be weighed naked.  Clinic visits are 
specified at 12-week intervals; however, it may be appropriate for subjects receiving 
emtricitabine oral solution to attend the clinic more frequently to be reweighed, to allow the 
dose of the emtricitabine oral solution (and, where appropriate, other antiretroviral 
medications) to be adjusted to reflect any change in their body weight.  In this case, the exact 
visit schedule will be left to the Investigator’s discretion, taking into account the age of the 
child and other relevant factors.  Regardless, no more than a 60-day supply of the 
emtricitabine oral solution may be dispensed to any subject (or his/her family) who does not 
have the means to adequately refrigerate the drug at home, thereby necessitating more 
frequent visits by the subject to the clinic to resupply the drug.
Dosing tables for emtricitabine are provided in Appendix 1 to the protocol.  These tables 
should be used to determine for each individual subject whether the child should receive 
capsules (body weight 33 kg) or oral solution and, if the latter, the volume of solution to be 
administered.

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Each dose of emtricitabine should be administered all at once using means appropriate for the 
age of the subject.  Sufficient water or other fluids should be offered to facilitate 
swallowing/washdown of emtricitabine, as necessary.  Emtricitabine can be dosed without 
regard to food.  It is recommended that the emtricitabine be given at the same time the 
subject takes his (or her) other antiretroviral medications.  A subject who vomits within 
30 minutes of taking his/her dose of emtricitabine should be re-dosed.
5.4.
Prior and Concomitant Medications
Currently, no drugs are contraindicated for co-administration with emtricitabine.  
Investigators should refer to the product/package inserts of the other antiretroviral 
medications for contraindications related to their use.

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6.
STUDY PROCEDURES
6.1.
Subject Enrollment and Treatment Assignment
Before enrolling in this study, subjects must have completed through at least 96 weeks on the 
FTC-203 study and complete the End-of-Study Visit procedures for FTC-203 (see 
Section 6.2.1 and Appendix 2 hereinafter for details).  The subject’s parent(s) or other legal 
guardian(s) must then provide written informed consent for him (or her) to participate in the 
rollover protocol.  Where applicable, depending on the age of the subject and prevailing 
institution practice regarding consenting minors, consent or assent may also be obtained from 
the subject.  Subjects who participate in this rollover protocol must meet the inclusion criteria 
detailed in Section 4.2.  To ensure uninterrupted treatment with the study drug, emtricitabine, 
if there is a reasonable expectation that the subject will meet the virologic criteria set out in 
Section 3.1, based on the results of HIV-1 RNA viral load testing performed at previous 
FTC-203 clinic visits, the End-of-Study Visit for the FTC-203 study and the Baseline visit of 
the rollover protocol can and should be completed at the same clinic visit, with the subject 
receiving his first supply of emtricitabine through the rollover protocol at that visit.
6.2.
Study Assessments
6.2.1.
End-of-Study Visit (FTC-203)/Baseline Visit (GS-US-162-0112)
For the End-of-Study Visit for the FTC-203 study, the following procedures will be 
completed:

Record height (or length) and body weight.

Perform a physical examination.

Obtain vital signs.

Obtain blood and urine samples for the following laboratory evaluations: CD4+ cell 
count, plasma HIV-1 RNA level, plasma for storage, hematology, chemistry and 
urinalysis

Female subjects of childbearing potential must have a urine pregnancy test performed.  If 
the urine pregnancy test is positive, a serum -HCG test should be performed and the GSI 
Medical Monitor contacted.

Record HIV-1 related events, adverse events, and concomitant medications.

Complete drug accountability, including ensuring that all previously unused FTC-203 
study medications(s), i.e., the study drug, emtricitabine, and, where applicable, the 
lopinavir-ritonavir and stavudine provided for ART-naïve subjects, is/are returned by the 
subject.

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The following procedures will be completed as part of the Baseline Visit for the 
GS-US-162-0112 rollover protocol:

Obtain written informed consent from parent or other legal guardian and, where 
applicable, the subject.

Review inclusion criteria for the rollover protocol.

Record height (or length) and body weight.

Review adverse events.

Complete drug accountability and provide a new supply of the study drug, emtricitabine 
for the rollover protocol.
Procedures required at both the End-of-Study Visit for FTC-203 and the Baseline Visit will 
not need to be repeated if done at the same clinic visit.  However, information may need to be 
recorded in the CRFs of both studies.
Genotypic analysis may be performed for subjects to determine whether they are eligible to 
participate in the rollover protocol.  If needed, genotypic analysis will be performed through 
the Clinical Virology group, GSI.  As necessary, each study center should contact the GSI 
Clinical Program Manager responsible for the rollover protocol to request approval for 
genotypic analysis, as well as sample collection and shipping instructions to the GSI office.
6.2.2.
Clinic Visits
During the rollover protocol, clinic visits will occur every 12 weeks.  At each visit, the 
Investigator will manage each subject’s care according to current “standard of care” practices 
at his (or her) institution, complete drug accountability and provide the subject with a new 
supply of emtricitabine.  Each Subject will continue to receive the study drug, emtricitabine, 
for as long as they continue to meet the following virologic criteria, either:

they have a plasma HIV-1 RNA viral load of 400 copies/mL, or

if the subject’s plasma HIV-1 RNA viral load is > 400 copies/mL, their viral load is 
< 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is 
reliable genotypic evidence showing a lack of resistance to emtricitabine.
At each clinic visit, the Investigator (or designee) will measure the child’s height (or length) 
and weight if the subject has not maintained the same height for three consecutive protocol 
visits (36 weeks), or if the height and weight are necessary to determine study drug dosage.
The Investigator (or designee) will assess adverse events, but only those AEs that (1) meet 
the criteria for an SAE, (2) that result in permanent discontinuation of the study drug, 
emtricitabine, and/or (3) are associated with skin discoloration (hyperpigmentation) will be 
recorded in the subject’s CRF.  Non-serious AEs that do not result in the discontinuation of 

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emtricitabine and/or are not associated with skin discoloration (hyperpigmentation), the 
results of routine clinical laboratory testing (hematology, clinical chemistry and urinalysis), 
immunological data (absolute and percent CD4+), pregnancy test results, and physical 
examination findings collected in the FTC-203 study will no longer be collected or recorded 
in their CRF, nor will the findings of any assessments done according to current standard of 
care practices be recorded in the CRF.  Information relating to the dispensing and 
accountability of the study drug will be recorded in the CRF.
HIV-1 RNA viral load levels will be assessed at each clinic visit to ensure continued subject 
eligibility, regarding the virologic criteria; however, these data will not be recorded in the 
CRF.  Genotypic analysis may be required to determine whether a subject is eligible to 
participate in the rollover protocol at the End-of-Study Visit for FTC-203 or after they have 
entered the rollover protocol to determine whether the subject has failed the criteria for 
virologic success and should permanently discontinue treatment with the study drug, 
emtricitabine.
Further study visits will be scheduled at approximately 12-week intervals (i.e., four times per 
year) for as long as the subject continues to meet the virologic criteria until such time as: 
(1) the subject chooses to withdraw from the rollover protocol and discontinue treatment of 
emtricitabine, (2) the subject experiences a toxicity that necessitates the permanent 
discontinuation of emtricitabine, or (3) emtricitabine is approved for market distribution in 
the subject’s country of residence.  The Investigator may choose to have the subject return to 
the clinic on a more frequent basis as part of their standard of care, but these visits will be 
outside of the protocol-defined study visit schedule.  Younger subjects receiving 
emtricitabine oral solution may need to attend the clinic more frequently than every 12 weeks 
to be reweighed to allow the dose of the emtricitabine oral solution (and, where appropriate, 
other antiretroviral medications) to be adjusted to reflect any change in their body weight.  In 
addition, for subjects receiving emtricitabine oral solution, if the subject does not have the 
means to adequately refrigerate the solution at home, it will also be necessary for him (or 
her) to make more frequent visits to the clinic to obtain fresh supplies of drug.  In the event
that a more frequent visit schedule is required, only drug dispensing and accountability 
information will be recorded in the CRF at those visits.
6.3.
Assessments for Premature Discontinuation From Study
If a subject discontinues the study drug, emtricitabine, regardless of reason, the Investigator 
should assess all reported AEs and complete drug accountability.  Any AE(s) that led to the 
permanent discontinuation of study drug should be recorded in the CRF.  The subject must 
return all unused study drug to the study center. The Investigator (or designee) will measure 
the child’s height (or length) and weight.
6.4.
Criteria for Suspension of Study Drug
Subjects who do not maintain plasma HIV-1 RNA levels as outlined in Section 6.2.2 above 
must be discontinued from study drug.  Furthermore, the study drug, emtricitabine, may be 
discontinued in the following instances:

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
Upon approval for market distribution in South Africa (and the subject has means to 
access the drug).

Unacceptable emtricitabine-related toxicity necessitating the permanent discontinuation 
of study drug.  Brief (generally 14 days) interruptions in treatment are permitted, 
e.g., to manage a newly emergent toxicity.  Longer (> 14 days) interruptions are 
permitted only with the approval of the GSI Medical Monitor and will be decided on a 
case-by-case basis.

Subject request to discontinue for any reason.

Subject non-compliance (in the judgment of the Investigator or Sponsor).

Subject pregnancy.

In the judgment of the Investigator or Sponsor, it is not considered to be in the subject’s 
best interest (for whatever reason) to continue in the rollover protocol.

Discontinuation of the rollover protocol at the request of GSI, applicable regulatory 
agency(ies) or IEC.

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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject 
administered a medicinal product and which does not necessarily have a causal relationship 
with this treatment.  An AE can therefore be any unfavorable and unintended sign, symptom, 
or disease temporally associated with the use of a medicinal product, whether or not 
considered related to the medicinal product. AEs may also include pre- or post-treatment 
complications that occur as a result of protocol-mandated procedures (e.g., invasive 
procedures such as venipuncture, biopsy, etc.).  Pre-existing events, which increase in 
severity or change in nature during or as a consequence of use of a medicinal product in 
human clinical trials, will also be considered AEs.
An AE does not include:

Medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, transfusion); 
the condition that leads to the procedure is an AE.

Pre-existing diseases or conditions or laboratory abnormalities present or detected prior 
to study entry that do not worsen.

Situations where an untoward medical occurrence has not occurred (e.g., hospitalization 
for elective surgery, social and/or convenience admissions).

Overdose without clinical sequelae (see Section 7.4).
7.2.
Assessment of Adverse Events
AEs that (1) meet the criteria for a serious adverse event (SAE) (as defined in Section 7.3), 
(2) lead to permanent discontinuation of the study drug, emtricitabine, and/or (3) are 
associated with skin discoloration (hyperpigmentation) will be assessed by the Investigator 
and recorded on the appropriate CRF page, including the date of onset and resolution, 
severity, relationship to study drug or study procedures, emtricitabine, outcome and action 
taken with the study drug.  No other AEs will be recorded.
Severity should be recorded and graded according to the GSI-modified DAIDS/NIAID 
Common Toxicity Grading Scale (see Appendices 3 and 4 to this protocol).  The relationship 
to the study drug, emtricitabine, or study procedures should be assessed using the following 
definitions:

No: Evidence exists that the AE has an etiology other than the study drug or study 
procedures (e.g., pre-existing condition, underlying disease, intercurrent illness, or 
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
Yes: A temporal relationship exists between the event onset and administration of the 
study drug or between the event and the study procedures.  It cannot be readily explained 
by the subject’s clinical state or concomitant therapies and, in the case of the study drug, 
appears with some degree of certainty to be related, based on the known therapeutic and 
pharmacologic actions or AE profile of the study drug.  In case of cessation or reduction 
of the dose, the event abates or resolves and reappears upon re-challenge.  It should be 
emphasized that ineffective treatment should not be considered as causally related in the 
context of AE reporting.
These criteria in addition to good clinical judgment should be used as a guide for determining 
the causal assessment.  If it is felt that the event is not related to the study drug, then an 
alternative explanation should be provided.
7.3.
Serious Adverse Events
A SAE is defined as follows:  
Any adverse drug experience occurring at any dose that results in any of the following 
outcomes:

Death;

Life-threatening situation (subject is at immediate risk of death);

In-patient hospitalization or prolongation of existing hospitalization (excluding those for 
study therapy or placement of an indwelling catheter, unless associated with other serious 
events);

Persistent or significant disability/incapacity;

Congenital anomaly/birth defect in the offspring of a subject who received study drug;

Other: medically significant events that may not result in death, be immediately 
life-threatening, or require hospitalization, may be considered a SAE when, based upon 
appropriate medical judgment, they may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition.
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
Development of drug dependency or drug abuse.

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Clarification of Serious Adverse Events

Death is an outcome of an AE, and not an AE in itself.  In reports of death due to 
“Disease Progression”, where no other information is provided, the death will be assumed 
to have resulted from progression of the disease being treated with the study drug.

All deaths, regardless of cause or relationship, must be reported for subjects on study and 
for deaths occurring within 30 days of last study drug dose or within 30 days of last study 
evaluation, whichever is longer.

“Occurring at any dose” does not imply that the subject is receiving study drug at the 
time of the event.  Dosing may have been given as treatment cycles or interrupted 
temporarily prior to the onset of the SAE, but may have contributed to the event.

“Life-threatening” means that the subject was at immediate risk of death from the event 
as it occurred.  This does not include an event that might have led to death, if it had 
occurred with greater severity.

Complications that occur during hospitalizations are AEs.  If a complication prolongs 
hospitalization, it is a SAE.

“In-patient hospitalization” means the subject has been formally admitted to a hospital for 
medical reasons, for any length of time.  This may or may not be overnight.  It does not 
include presentation and care within an emergency department.

The Investigator should attempt to establish a diagnosis of the event based on signs, 
symptoms and/or other clinical information.  In such cases, the diagnosis should be 
documented as the AE and/or SAE and not the individual signs/symptoms.
A distinction should be drawn between serious and severe AEs.  An AE that is assessed as 
grade 4 (potentially life-threatening) should not be confused with a SAE.  Severity is a 
category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed 
as grade 4.
7.4.
Special Situations Reports
7.4.1.
Definitions of Special Situations
Special situation reports include pregnancy reports, reports of medication error, abuse, 
misuse,or overdose, and reports of adverse reactions associated with product complaints.
For this study, a pregnancy report is used to report pregnancies following maternal exposure 
to the product. 
Medication error is any unintentional error in the prescribing, dispensing or administration of 
a medicinal product while in the control of the HCP, patient or consumer.

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Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by 
a patient.
Misuse is defined as any use of a medicinal product in a way that the product is intentionally 
and inappropriately used not in accordance with the protocol instructions or the local 
prescribing information.
An overdose is defined as a dose taken (accidentally or intentionally) exceeding the dose as 
prescribed by the protocol (as it applies to the dose for the subject in question). In cases of a 
discrepancy in drug accountability, overdose will be established only when it is clear that the 
subject has taken the excess dose(s) or the investigator has reason to suspect that the subject 
has taken the additional dose(s).
Product complaint is defined as any written or verbal report arising from potential deviations 
in the manufacture, packaging or distribution of the product.
7.4.2.
Instructions for Reporting Special Situations
7.4.2.1.
Instructions for Reporting Pregnancies
The Investigator should report all pregnancies to Gilead DSPH using the Pregnancy Report 
form within 24 hours of becoming aware of the pregnancy.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate 
a pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as 
an SAE. The underlying medical reason for this procedure should be recorded as the adverse 
event term.
A spontaneous abortion is always considered to be an SAE and will be reported as described 
in the Adverse and Serious Adverse Events section. Furthermore, any SAE occurring as an 
adverse pregnancy outcome post-study must be reported to Gilead Sciences.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead DSPH using the Pregnancy Outcome 
Report form. If the end of the pregnancy occurs after the study has been completed, the 
outcome should be reported directly to Gilead DSPH. Gilead DSPH contact information is as 
follows: Email: Safety_FC@gilead.com and Fax: +1 (650) 522-5477.
Refer to Section 7.9 for Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Recommendations.

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All other Special Situation rep01is must be rep01ied on the Special Situations Rep01i F01m 
and f01warded to Gilead DSPH within 24 homs. Gilead DSPH contact infonnation is as 
follows: Email: Safety_FC@gilead.com and Fax:+ 1 (650) 522-5477. 
All clinical sequelae in relation to these special situation rep01is that meet criteria for AE or 
SAE rep01iing will be rep01ied as AEs or SAEs at the same time using the AE eCRF and/or 
the SAE rep01i f01m. Details of the symptoms and signs, clinical management and outcome 
will be rep01ied, when available. 
7.5. 
Serious Adverse Event Reporting Requirements 
7.5.1. 
All Serious Adverse Events 
GSI has requirements for expedited rep01iing of SAEs meeting specific requirements to 
worldwide regulat01y authorities; therefore, GSI must be notified immediately regarding the 
occun ence of any SAE that occms after the screening (initial) visit, including SAEs resulting 
from study procedmes perfonned from screening onwards. The procedmes for rep01iing all 
SAEs, regardless of causal relationship, are as follows: 
• 
Record the SAE on the AE CRF and complete the "Serious Adverse Event Rep01i" f01m. 
• 
Fax the SAE rep01i to the attention of the Gilead Depmiment of Safety and Public Health 
(DSPH) SAE Report Fonn within 24 homs of the Investigator's knowledge of the event. 
GDS contact inf01mation is provided below. 
• 
For fatal or life-threatening events, also fax copies of hospital case rep01is, autopsy 
rep01is, and other documents when requested and applicable. 
Gilead Sciences DSPH: 
Telephone: 
Fax: 
Email: 
GSI Medical Monitor: 
Name: 
Telephone: 
Fax: 
Mobile: 
Email: 
PPD 
PPD 
safety Jc@glleaa.com 
Erin Quirk, M.D. 
PPD 
PPD 
PPD 
PPD 
• 
For fatal or life-threatening events, also e-mail or fax copies of hospital case rep01is, 
autopsy rep01is, and other documents when requested and applicable. Transmission of 
such documents should occm with Personal Subject Details de-identified, without losing 
the u·aceability of a document to the Subject Identifiers. 
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
Gilead Sciences may request additional information from the Investigator to ensure the 
timely completion of accurate safety reports.
The Investigator must take all therapeutic measures necessary for resolution of the SAE.  
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF.
Follow-up of AEs will continue through the last day on study (including the follow-up, off 
study drug period of the study), until the Investigator and/or GSI determine that the subject’s 
condition is stable, or up to 30 days after the last dose of study drug, whichever is longer.  
GSI may request that certain AEs be followed until resolution.
7.5.2.
Investigator Reporting Requirements for SAEs
A SAE may qualify for reporting to regulatory authorities if the SAE is possibly attributable 
to the study drug, and is unexpected based upon the current Company Core Safety 
Information appended to the emtricitabine Investigator’s Brochure.  In this case, all 
Investigators will receive a formal notification describing the SAE.
The Investigator should notify the Independent Ethics Committee (IEC) as soon as is 
practical, of serious events in writing where this is required by local regulatory authorities, 
and in accordance with the local institutional policy.
7.5.3.
Post Study Reporting Requirements
All deaths, regardless of cause or relationship, must be reported for subjects on study and for 
all deaths occurring within 30 days of last study drug dose.
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Clinical laboratory abnormalities (e.g., clinical chemistry, hematology or urinalysis) or other 
abnormal findings (e.g., electrocardiogram, X-rays or vital signs) performed as part of 
current standard of care should not be recorded as adverse events in the CRF unless serious 
and/or they lead to the discontinuation of study drug, emtricitabine.  Wherever possible, the 
Investigator should attempt to establish a diagnosis of the event, based on signs, symptoms 
and/or other clinical information.  In such cases, the diagnosis should be documented as the 
AE and/or SAE and not the individual signs/symptoms.  The results of routine clinical 
laboratory (hematology, clinical chemistry and urinalysis), immunological data (absolute and 
percent CD4+), pregnancy test results, and physical examination findings collected in the 
FTC-203 study will no longer be collected or recorded in the CRF, nor will the findings of 
any assessments done according to current standard of care practices during the rollover 
protocol be recorded in the CRF.

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7.7.
Toxicity Management
Clinical events that meet the criteria for an SAE and/or that lead to discontinuation of the 
study drug, emtricitabine, will be graded according to the GSI-modified DAIDS/NIAID 
Common Toxicity Grading Scale (see Appendices 3 and 4).  The relationship to study drug 
or study procedures will be assessed using the definitions outlined in Section 7.2.
For any toxicity, Investigators are urged to identify the drug most likely to be the cause of the 
toxicity and change that drug or dosage, if possible.  To manage specific toxicities associated 
with background antiretroviral medications, the Investigator should follow the current 
package insert, manufacturer’s guidelines and/or Investigator’s Brochure for the individual 
drugs.  If a subject becomes intolerant to emtricitabine, the decision to interrupt, dose adjust 
and/or discontinue the medication must be promptly communicated to the GSI Medical 
Monitor.  Brief (generally 14 days) interruptions in treatment are permitted, e.g., to manage 
a newly emergent toxicity.  Longer (> 14 days) interruptions are permitted only with the 
approval of the GSI Medical Monitor and will be decided on a case-by-case basis.  The GSI 
Medical Monitor will be available for consultation on all toxicity-related issues (see 
Section 7.5.1 for contact information).
7.8.
Major Toxicities of Emtricitabine
The most common side effects seen in subjects treated with emtricitabine in combination 
with other anti-HIV drugs are: allergic reaction, headache, dizziness, insomnia, abnormal 
dreams, diarrhea, nausea, vomiting, problems with digestion resulting in gastrointestinal 
discomfort after meals, abdominal pain, rash, changes in skin color on the palms and/or soles, 
pain, feeling tired or weak, increased triglycerides levels, adverse effects on the function of 
the liver (e.g., elevated bilirubin), and pancreas, increased blood glucose, and low white 
blood cell count.  Increases in creatine kinase, associated with muscle pain and weakness, 
have also been reported.  Anemia has been reported in pediatric subjects treated with 
emtricitabine.
See the emtricitabine Investigator’s Brochure for more detailed information.
7.8.1.
Skin Discoloration
In the adult clinical trials, skin discoloration was reported more frequently in patients treated 
with emtricitabine, as compared to patients enrolled in control groups {7095}.  The skin 
discoloration occurred as hyperpigmentation, most commonly on the palms and/or soles, and 
was always mild or moderate, generally asymptomatic and without association with any 
pathologic skin condition.
In the event that a subject should develop hyperpigmentation while participating in this 
rollover protocol, the hyperpigmentation should be documented in the CRF as an adverse 
event and a Hyperpigmentation Assessment CRF completed.  In addition, the subject may be 
required to have one or more dermatological consultations and possibly other explorations, as 

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deemed necessary by the dermatologist.  Any relevant medical consultation should be 
retained in the study files and appended to the subject’s CRF.
7.9.
Contraception Requirements for Males and Females of Childbearing 
Potential
The risks of treatment with the study drugs during pregnancy have not been evaluated. If 
females are using hormonal agents for contraception, the safety and/or efficacy may be 
affected by possible drug-drug interaction.  Subjects receiving hormonal contraceptives 
should consider additional methods of contraception as concentrations of ethinyl estradiol 
may decrease and progestin level may increase on coadministration with study drugs.  If 
females utilize hormonal agents as one of their contraceptive methods, it is required that the 
same hormonal method be used for at least 3 months before study dosing.
For additional information, please refer to the Prescribing Information for Emtricitabine.
7.9.1.
Definition of Female of Childbearing Potential
For the purposes of this study, a female subject of childbearing potential is a woman who has 
not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure. 
This includes pubertal females regardless of whether or not she has had a menses 
(premenarchal, Tanner Stage 3) and perimenopausal women who have had a spontaneous 
menses in the last 12 months.

Women ≤54 years of age with amenorrhea of any duration will be considered to be of 
childbearing potential. Exceptions must be discussed with the Medical Monitor.

Women > 54 years of age with cessation (for ≥12 months) of previously occurring 
menses due to ovarian failure will not be considered to be of childbearing potential.
7.9.2.
Contraception Requirements 
Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol-recommended method(s) of contraception from 
3 weeks prior to baseline, throughout the study period and for 30 days following the last dose 
of study medication. The investigator should counsel subjects on the protocol-recommended 
method(s) for avoiding pregnancy during the trial. These methods are recommended due to 
the low failure rate (i.e., less than 1% per year). See Table 7-1 for the protocol-recommended 
methods.
Female study subjects who are not heterosexually active must have periodic confirmation of 
continued abstinence from heterosexual intercourse as a lifestyle choice and regular 
pregnancy testing while taking study drugs. The investigator should counsel subjects on the 
protocol-recommended method(s) for avoiding pregnancy in case subject chooses to engage 
in heterosexual intercourse.

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Female subjects of childbearing potential must have a negative serum pregnancy test at 
Screening and at Baseline (Day -1) prior to receiving the first dose of study drug. Lactating 
females must discontinue nursing before investigational medicinal product administration.
Table 7-1.
Protocol-Recommended Contraceptive Methods
Methods to Use by 
Themselves
Combination Methods
Hormone Methods
(choose one and use with a barrier 
method)
Barrier Methods
(use both OR choose one and use 
with a hormone method)
Intra-uterine devices (IUDs)

Copper T 380A IUD

LNg 20 IUD
Tubal sterilization
Estrogen and Progesterone

Oral contraceptives

Transdermal Patch

Vaginal Ring
Progesterone

Injection

Implant

Diaphragm with spermicide
OR
Cervical cap with spermicide

Male condom (no lambskin 
condoms and without 
spermicide)
Partner’s vasectomy must be used along with a hormone or barrier method.
Acceptable barrier methods include: diaphragm (with spermicide), cervical cap (with 
spermicide), and the male condom (except lambskin). 
Female subjects who utilize hormonal contraceptives as one of their birth control methods 
must have used the same method for at least 3 months before study dosing.
If tubal sterilization is via the Essure procedure, verification of tubal blockage by 
hysterosalpingogram (HSP) must be performed approximately 3 months after 
micro-insertion. Prior to verification, Essure is not considered a reliable form of 
contraception and another contraception method described above should be used.
Other contraceptive methods may be acceptable after discussion with the Medical Monitor.
7.9.3.
Additional Requirements for Male Subjects
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm 
donation while enrolled in the study and for 30 days after administration of the last dose of 
study drug.
Use of condoms (except for lambskin) should be encouraged for all participants because they 
have been proven to decrease the risk of transmission of HIV and other sexually transmitted 
diseases. The use of spermicide is not recommended if the subject or subject’s partner is 
HIV-infected.

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7.9.4.
Risks for Women of Childbearing Potential or During Pregnancy
The risks of treatment with the study drug, emtricitabine, during pregnancy have not been 
evaluated.  Animal studies do not indicate direct or indirect harmful effects of emtricitabine 
with respect to pregnancy.  Please refer to the latest version of the Investigator’s Brochure for 
additional information.  Barrier contraception should always be used in combination with 
other methods of contraception (e.g., oral or other hormonal contraceptives) by females of 
child bearing potential who are less than 2 years post-menopausal while participating in the 
study and for 30 days following the last dose of study drug.  Male subjects in the study who 
are sexually active must use barrier contraception for the same period of time with their 
female partners of childbearing potential or agree to abstain from heterosexual intercourse for 
the duration of their participation in the study.
The subject must be instructed to discontinue the study drug (and other medications, as 
applicable) and inform the Investigator immediately if she becomes pregnant during the 
study.
The Investigator should report all pregnancies to the GSI within 24 hours of becoming aware 
of the pregnancy.  The Investigator should counsel the subject regarding the possible effects 
of prior study drug exposure on the fetus and the need to inform the study center of the 
outcome of the pregnancy.
Any pregnancy complication or elective termination of a pregnancy for medical reasons will 
be recorded as an SAE.  A spontaneous abortion is always considered to be an SAE and will 
be reported as described in the AE and SAE sections.  Furthermore, any SAE occurring as an 
adverse pregnancy outcome post-study must be reported to GSI.
Additionally all pregnancies that occur during the study should be reported using the 
Pregnancy Report CRF page.  Monitoring of the subject should continue until the conclusion 
of the pregnancy.  The outcome should be reported to GSI using the Pregnancy Outcome 
(and Abnormal Pregnancy Outcome, if applicable) CRF page(s).  If the end of the pregnancy 
occurs after the study has been complete, the outcome should be reported directly to GSI.  
Pregnancies that occur after the subject has discontinued study drugs do not require 
monitoring.

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8.
STATISTICAL CONSIDERATIONS
No statistical analysis are planned. Data listings will be generated for all data collected in the 
clinical database.  Listings will include subject enrollment/disposition, demographics (from 
the FTC-203 clinical database), SAEs, AEs leading to permanent discontinuation of study 
drug, emtricitabine, AEs associated with skin discoloration (hyperpigmentation), and study 
drug dispensing/accountability.  Tabular summaries will be prepared.

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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The Investigator will ensure that this study is conducted in full compliance with the 
principles of the “Declaration of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong 
Kong, and South Africa), ICH guidelines, or with the laws and regulations of the country in 
which the research is conducted, whichever affords the greater protection to the study 
subject.  For studies conducted under a US IND, the Investigator will ensure that the basic 
principles of “Good Clinical Practice,” as outlined in 21 CFR 312, subpart D, 
“Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 1998, and 21 CFR, part 
56, 1998, are adhered to.
9.1.2.
Independent Ethics Committee Approval
This protocol and any accompanying material to be provided to the subject (such as 
advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) will be submitted, by the Investigator, to an independent ethics committee 
(IEC) and, where applicable, to the relevant regulatory and/or health authorities in each 
respective country.  Approval from the IEC and, where applicable, the relevant 
regulatory/health authority(ies) must be obtained before starting the study and should be 
documented in a letter to the Investigator specifying the protocol number, protocol version, 
documents reviewed, and date on which the IEC met and granted the approval.
Any modifications made to the protocol after receipt of IEC approval must also be submitted 
to the IEC and, where applicable, the relevant regulatory/health authority(ies) for approval 
prior to implementation.
9.1.3.
Informed Consent
It is the responsibility of the Investigator to obtain written informed consent from each 
individual participating in this study after adequate explanation of the aims, methods, 
objectives, and potential hazards of the study and prior to undertaking any study-related 
procedures.  The Investigator must utilize an IEC-approved consent form for documenting 
written informed consent.  Each informed consent will be appropriately signed and dated by 
the subject or the subject’s legally authorized representative and the person obtaining 
consent.
9.1.4.
Confidentiality
The Investigator must assure that subjects’ anonymity will be strictly maintained and that 
their identities are protected from unauthorized parties.  Only subject initials and an 
identification code (i.e., not names) should be recorded on any form submitted to the Sponsor 

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and IEC.  The Investigator must keep a screening log showing codes, names, and addresses 
for all subjects screened and for all subjects enrolled in the trial.
The Investigator agrees that all information received from GSI, including but not limited to 
the Investigator’s Brochure, this protocol, CRFs, the investigational new drug, and any other 
study information remain the sole and exclusive property of GSI during the conduct of the 
study and thereafter.  This information is not to be disclosed to any third party (except 
employees or agents directly involved in the conduct of the study or as required by law) 
without prior written consent from GSI.  The Investigator further agrees to take all 
reasonable precautions to prevent the disclosure by any employee or agent of the study site to 
any third party or otherwise into the public domain.
9.1.5.
Study Files and Retention of Records
The Investigator must maintain adequate and accurate records to enable the conduct of the 
study to be fully documented and the study data to be subsequently verified.  These 
documents should be classified into two separate categories (although not limited to) the 
following: (1) Investigator’s study file, and (2) subject clinical source documents.
The Investigator’s study file will contain the protocol/amendments, CRF and query forms, 
IEC and governmental approval with correspondence, informed consent, drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and 
correspondence.
Subject clinical source documents (usually defined by the project in advance to record key 
efficacy/safety parameters independent of the CRFs) would include (although not, limited to) 
the following: subject hospital/clinic records, physician’s and nurse’s notes, appointment 
book, original laboratory reports, electrocardiogram, electroencephalogram, X-ray, pathology 
and special assessment reports, consultant letters, screening and enrollment log, etc.
All clinical study documents must be retained by the Investigator until at least two years after 
the last approval of a marketing application in an International Conference on Harmonization 
(ICH) region (i.e., US, Europe, or Japan) and until there are no pending or contemplated 
marketing applications in an ICH region; or, if no application is filed or if the application is 
not approved for such indication, until two years after the investigation is discontinued and 
regulatory authorities have been notified.  Investigators may be required to retain documents 
longer if required by applicable regulatory requirements or an agreement with GSI.  The 
Investigator must notify GSI Sciences prior to destroying any clinical study records.
Should the Investigator wish to assign the study records to another party or move them to 
another location, GSI must be notified in advance.
If the Investigator cannot guarantee this archiving requirement at the study site for any or all 
of the documents, special arrangements must be made between the Investigator and GSI to 
store these in sealed containers outside of the site so that they can be returned sealed to the 
Investigator in case of a regulatory audit.  Where source documents are required for the 

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continued care of the subject, appropriate copies should be made for storage outside of the 
site.
9.1.6.
Case Report Forms
For each subject enrolled, a CRF must be completed and signed by the Investigator or 
Sub-investigator within a reasonable time period after data collection.  This also applies to 
records for those subjects who fail to complete the study.  If a subject withdraws from the 
study, the reason must be noted on the CRF.  If a subject is withdrawn from the study 
because of a treatment-limiting AE, thorough efforts should be made to clearly document the
outcome.
9.1.7.
Drug Accountability
The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate 
accountability of all used and unused study drug.  This includes acknowledgment of receipt 
of each shipment of study product (quantity and condition) and subject dispensing records 
and returned or destroyed study product.  Dispensing records will document quantities 
received from GSI and quantities dispensed to subjects, including lot number, date dispensed, 
subject identifier number, subject initials, and the initials of the person dispensing the 
medication.
At study initiation, the monitor will evaluate the site’s standard operating procedure for study 
drug disposal/destruction in order to ensure that it complies with GSI requirements.  Drug 
may be returned or destroyed on an ongoing basis during the study if appropriate.  At the end 
of the study, following final drug inventory reconciliation by the monitor, the study site will 
dispose of and/or destroy all unused study drug supplies, including empty containers, 
according these procedures.  If the site cannot meet GSI’s requirements for disposal, 
arrangements will be made between the site and GSI or it’s representative, for destruction or 
return of unused study drug supplies.
All drug supplies and associated documentation will be periodically reviewed and verified by 
the study monitor over the course of the study.
9.1.8.
Inspections
The Investigator should understand that source documents for this trial should be made 
available to appropriately qualified personnel from GSI or its representatives, to IECs, or to 
regulatory authority or health authority inspectors.
9.1.9.
Protocol Compliance
The Investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.

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9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, 
may be made only by GSI.  All protocol modifications must be submitted to the IEC in 
accordance with local requirements.  Approval must be obtained before changes can be 
implemented.
9.2.2.
Study Report and Publications
After conclusion of the study and without prior written approval from GSI, Investigators in 
this study may communicate, orally present, or publish in scientific journals or other 
scholarly media only after the following conditions have been met:

the results of the study in their entirety have been publicly disclosed by or with the 
consent of GSI in an abstract, manuscript, or presentation form; or

the study has been completed at all study sites for at least 2 years.
No such communication, presentation, or publication will include GSI’s confidential 
information (see Section 9.1.4).
The Investigator will submit any proposed publication or presentation along with the 
respective scientific journal or presentation forum at least 30 days prior to submission of the 
publication or presentation.  The Investigator will comply with GSI’s request to delete 
references to its confidential information (other than the study results) in any paper or 
presentation and agrees to withhold publication or presentation for an additional 60 days in 
order to obtain patent protection if deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Access to Information for Monitoring
In accordance with International Conference on Harmonisation Good Clinical Practice 
(ICH-GCP) guidelines, the study monitor must have direct access to the Investigator’s source 
documentation in order to verify the data recorded in the CRFs for consistency.
The monitor is responsible for routine review of the CRFs at regular intervals throughout the 
study, to verify adherence to the protocol, and the completeness, consistency and accuracy of 
the data being entered on them.  The monitor should have access to any subject records 
needed to verify the entries on the CRFs.  The Investigator agrees to cooperate with the 
monitor to ensure that any problems detected in the course of these monitoring visits are 
resolved.

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9.3.2.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of GSI may conduct inspections or audits of the 
clinical study.  If the Investigator is notified of an inspection by a regulatory authority the 
Investigator agrees to notify the GSI Medical Monitor immediately.  The Investigator agrees 
to provide to representatives of a regulatory agency or GSI access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.3.
Study Discontinuation
Both the Sponsor and the Investigator reserve the right to terminate the study at any time.  
Should this be necessary, both parties will arrange discontinuation procedures and notify the 
appropriate regulatory/health authority(ies) and IECs.  In terminating the study, GSI and the 
Investigator will assure that adequate consideration is given to the protection of the subjects’ 
interests.

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10.
REFERENCES
7095
Mondou E, Hinkle J, Shaw A, Quinn J, Adda N, Rousseau F. Incidence of skin 
discoloration across phase 3 clinical trials of emtricitabine (FTC) in adults [poster 
5916]. XV International AIDS Conference; 2004 July 11-16; Bangkok, Thailand. 
7438
Saez-Llorens X, Violari A, Ndiweni D, Avila-Figueroa C, Wiznia A, Blum MR, et 
al. Once Daily Emtricitabine (FTC) in HIV-Infected Pediatric Patients with Other 
Antiretroviral Agents [Poster 872]. 10th Conference on Retroviruses and 
Opportunistic Infections; 2003 February 10-14; Boston, MA. 

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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Emtricitabine (Emtriva) Dose Tables
Appendix 3.
Study Procedures Table
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities

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Appendix l. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DR. 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa 
with Continued Access to Emtricitabine 
GS-US-162-0112 Protocol Amendment: 24 July 2013 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
Erin Quirk, MD 
Author 
Date 
' 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
r will provide all study personnel under my supervision copies of the protocol and access to 
all information provided by Gilead Sciences, Inc. I will discuss this material with them to 
ensure that they are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
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Appendix 2.
Emtricitabine (Emtriva) Dose Tables
EMTRIVACAPSULE, 200 mg
Body Weight Range
(kg)
Calculated Dose Range at 
6 mg/kg
(mg)
Actual Dose To 
Administer
(mg)
Number of 200 mg 
Capsules To Administer
< 32.9
N/A
NA
Use Solution
33
189.6
200
1
EMTRIVAORAL SOLUTION, 10 mg/mL
Body Weight Range (kg)
Calculated Dose Range at 
6 mg/kg (mg)
Actual Dose To 
Administer (mg)
Volume of 10 mg/mL 
Solution to Administer 
(mL)
Min.
Max.
Min.
Max.
2.5
3.3
15.0
19.8
20
2.0
3.4
4.1
20.4
24.6
25
2.5
4.2
4.9
25.2
29.4
30
3.0
5.0
5.7
30.0
34.2
35
3.5
5.8
6.5
34.8
39.0
40
4.0
6.6
7.4
39.6
44.4
45
4.5
7.5
8.2
45.0
49.2
50
5.0
8.3
9.1
49.8
54.6
55
5.5
9.2
10.0
55.2
60.0
60
6.0
10.1
10.8
60.6
64.8
65
6.5
10.9
11.6
65.4
69.6
70
7.0
11.7
12.5
70.2
75.0
75
7.5
12.6
13.3
75.6
79.8
80
8.0
13.4
14.1
80.4
84.6
85
8.5
14.2
15.0
85.2
90.0
90
9.0
15.1
15.8
90.6
94.8
95
9.5
15.9
16.6
95.4
99.6
100
10.0
16.7
18.3
100.2
109.8
110
11.0
18.4
20.0
110.4
120.0
120
12.0
20.1
21.6
120.6
129.6
130
13.0
21.7
23.3
130.2
139.8
140
14.0
23.4
25.0
140.4
150.0
150
15.0

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EMTRIVAORAL SOLUTION, 10 mg/mL
Body Weight Range (kg)
Calculated Dose Range at 
6 mg/kg (mg)
Actual Dose To 
Administer (mg)
Volume of 10 mg/mL 
Solution to Administer 
(mL)
Min.
Max.
Min.
Max.
25.1
26.6
150.6
159.6
160
16.0
26.7
28.3
160.2
169.8
170
17.0
28.4
30.0
170.4
180.0
180
18.0
30.1
31.5
180.6
189.0
190
19.0
31.6
33.3
189.6
199.8
200
20.0*
33.4
35.0
200.4
210.0
210
21.0*
35.1
36.6
210.6
219.6
220
22.0*
36.7
38.3
220.2
229.8
230
23.0*
38.4
230.4
240
24.0*
For subjects able to swallow solid medication, use the capsule formulation.

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Appendix 3. 
Study Procedures Table 
FTC-203 
Assessment 
End-of-Studl 
hummed Consent 
Review offucl./Excl. 
Criteria 
Physical Examination 
X 
Height/WeightNital Signs 
X 
Hematology 
X 
Chemistry 
X 
Urinalysis 
X 
Pregnancy Test6 
X 
CD4+ Cell Count 
X 
Plasma HIV -1 RNA Levels 
X 
Plasma for Storage (5 mL) 
X 
Record Adverse Events 
X 
Record HIV -1 Related 
X 
Events 
Study Drug Accountability 
X 
Dispense Study Thug8 
Concomitant Medications 
X 
GS-US-162-01121 
Baselinl' Visit3 
+ each 12 weeks4 
X 
X 
5 
X 
5 
X 
X 
X 
x7 
x7 
X 
X 
X 
X 
Final 
Amendment 1 
Subject Discontinuation 
5 
X 
X 
x7 
X 
Only for qualifying subjects, i.e., subjects who meet the virologic criteria for c.ontinuation of emtricitabine at the End-of-Study Visit for FTC-203 (see Section 6.2.2). 
CONFIDENTIAL 
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2
These assessments will be performed on all subjects who discontinue the FTC-203 study, regardless of reason, including those subjects who complete the FTC-203 study 
and who elect not to participate in the rollover protocol.
3
If there is a reasonable expectation that the subject will continue to meet the virologic criteria for continuation of emtricitabine, based on the results of HIV-1 RNA viral 
load testing performed during the FTC-203 study, then the End-of-Study Visit for FTC-203 and the Baseline Visit of the GS-US-162-0112 rollover protocol may be 
completed at the same clinic visit.
4
The Investigator may choose to have the subject return to the clinic on a more frequent basis, e.g., as part of their standard of care, and/or to resupply the study drug(s) 
(and other medications) but these visits will be outside of the protocol-defined visit schedule.
5
Height (or length) and body weight only, if the subject has not maintained the same height for three consecutive protocol visits (36 weeks), or if the height and weight are 
necessary to determine study drug dosage. 
6
If the pregnancy test is positive, discontinue emtricitabine and contact GSI.  A positive urine -HCG test should be confirmed with a serum -HCG test, per the FTC-203 
protocol.
7
Adverse events will only be recorded in the CRF if the event (s) is (1) serious, (2) results in the permanent discontinuation of study drug, emtricitabine, and/or (3) is 
associated with skin discoloration (hyperpigmentation).
8
Subjects will receive emtricitabine, in combination with other antiretroviral medications, at 6 mg/kg once daily (QD), up to a maximum of 200 mg QD using the capsule 
formulation or up to 240 mg QD using the oral solution formulation, each administered orally, for as long as the subject continues to demonstrate virologic success.  
Although assessments are scheduled at 12-week intervals, no more than a 60-day supply of emtricitabine oral solution may be dispensed to subjects who do not have 
means to adequately refrigerate the drug at home, thereby necessitating more frequent visits by the subject to the clinic to resupply the study drug.  Drug accountability 
information will be recorded at those visits.

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Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Version: 18 June 2012
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hemoglobin
HIV POSITIVE
Adult and Pediatric 57 
Days
8.5 to 10.0 g/dL 
85 to 100 g/L
7.5 to 8.5 g/dL 
75 to 85 g/L
6.5 to 7.5 g/dL 
65 to 75 g/L
6.5 g/dL
65 g/L
HIV NEGATIVE
Adult and Pediatric 57 
Days
10.0 to 10.9 g/dL
100 to 109 g/L
OR
Any decrease
2.5 to 3.5 g/dL
25 to 35 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
OR
Any decrease
3.5 to 4.5 g/dL
35 to 45 g/L
7.0 to 9.0 g/dL
70 to 90 g/L
OR
Any decrease
4.5 g/dL
45 g/L
7.0 g/dL
70 g/L
Infant, 36–56 Days
(HIV POSITIVE OR 
NEGATIVE)
8.5 to 9.4 g/dL
85 to 94 g/L
7.0 to 8.5 g/dL
70 to 85 g/L
6.0 to 7.0 g/dL
60 to < 70 g/L
6.0 g/dL
< 60 g/L
Infant, 22–35 Days
(HIV POSITIVE OR 
NEGATIVE)
9.5 to 10.5 g/dL
95 to 105 g/L
8.0 to 9.5 g/dL
80 to 95 g/L
7.0 to 8.0 g/dL
70 to 80 g/L
7.0 g/dL
70 g/L
Infant, 1–21 Days
(HIV POSITIVE OR 
NEGATIVE)
12.0 to 13.0 g/dL
120 to 130 g/L
10.0 to 12.0 g/dL
100 to 120 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
9.0 g/dL
90 g/L

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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Absolute Neutrophil Count 
(ANC)
Adult and Pediatric, 
7 Days
1000 to 1300/mm3
750 to 1000/mm3
500 to 750/mm3
500/mm3
1.00 to 1.30 GI/L
0.75 to 1.00 GI/L
0.50 to 0.75 GI/L
0.50 GI/L
Infant, 2 – 7 Days
1250 to 1500/mm3
1.25 to 1.50 GI/L
1000 to 1250/mm3
1.00 to < 1.25 GI/L
750 to 1000/mm3
0.75 to < 1.00 GI/L
750/mm3
< 0.75 GI/L
Infant, 1 Day
4000 to 5000/mm3
4.00 to 5.00 GI/L
3000 to 4000/mm3
3.00 to < 4.00 GI/L
1500 to 3000/mm3
1.50 to < 3.00 GI/L
1500/mm3
< 1.50 GI/L
Absolute CD4+ Count
HIV NEGATIVE ONLY
Adult and Pediatric 
> 13 Years
300 to 400/mm3
300 to 400/microL
200 to 300/mm3
200 to 300/microL
100 to 200/mm3
100 to 200/microL
100/mm3
100/microL
Absolute Lymphocyte Count
HIV NEGATIVE ONLY
Adult and Pediatric 
13 Years
600 to 650/mm3
0.60 to 0.65 GI/L
500 to 600/mm3
0.50 to 0.60 GI/L
350 to 500/mm3
0.35 to 0.50 GI/L
350/mm3
0.35 GI/L
Platelets 
100,000 to < 125,000/mm3
100.0 to 125.0 GI/L
50,000 to 100,000/mm3
50.0 to 100.0 GI/L
25,000 to 50,000/mm3
25.0 to 50.0 GI/L
25,000/mm3
25.0 GI/L
WBCs 
2000/mm3 to 2500/mm3
1,500 to 2,000/mm3
1000 to 1,500/mm3
1000/mm3
2.0 GI/L to 2.5 GI/L
1.5 to 2.0 GI/L
1.0 to 1.5 GI/L
1.0 GI/L

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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hypofibrinogenemia
100 to LLN mg/dL
75 to 100 mg/dL
50 to 75 mg/dL
50 mg/dL
1.00 to LLN g/L
0.75 to 1.00 g/L
0.50 to 0.75 g/L
0.50 g/L
Hyperfibrinogenemia
ULN to 600 mg/dL
600 mg/dL
—
—
ULN  to 6.0 g/L
6.0 g/L
Fibrin Split Product 
20 to 40 microg/mL
40 to 50 microg/mL
50 to 60 microg/mL
60 microg/mL
20 to 40 mg/L
40 to 50 mg/L
50 to 60 mg/L
60 mg/L
Prothrombin Time (PT)
1.00 to 1.25 ULN
1.25 to 1.50 ULN
1.50 to 3.00 ULN
3.00 ULN
Activated Partial
Thromboplastin (APPT)
1.00 to 1.66 ULN
1.66 to 2.33 ULN
2.33 to 3.00 ULN
3.00 ULN
Methemoglobin 
5.0 to 10.0%
10.0 to 15.0%
15.0 to 20.0%
20.0%

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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyponatremia 
130 mEq/L to LLN
125 to 130 mEq/L
121 to 125 mEq/L
121 mEq/L
130 mmol/L to LLN
125 to 130 mmol/L
121 to 125 mmol/L
121 mmol/L
Hypernatremia 
ULN to 150 mEq/L
150 to 154 mEq/L
154 to 159 mEq/L
159 mEq/L
ULN to 150 mmol/L
150 to 154 mmol/L
154 to 159 mmol/L
159 mmol/L
Hypokalemia 
3.0 mEq/L to LLN
2.5 to 3.0 mEq/L
2.0 to 2.5 mEq/L
2.0 mEq/
3.0 mmol/L to LLN
2.5 to 3.0 mmol/L
2.0 to 2.5 mmol/L
2.0 mmol/L
Hyperkalemia 
5.6 to 6.0 mEq/L
6.0 to 6.5 mEq/L
6.5 to 7.0 mEq/L
7.0 mEq/L
5.6 to 6.0 mmol/L
6.0 to 6.5 mmol/L
6.5 to 7.0 mmol/L
7.0 mmol/L
Hypoglycemia
Adult and Pediatric
1 Month
55 to 64 mg/dL
40 to 55 mg/dL
30 to 40 mg/dL
30 mg/dL
3.1 to 3.5 mmol/L
2.2 to 3.1 mmol/L
1.7 to 2.2 mmol/L
1.7 mmol/L
Infant, 1 Month
50 to 54 mg/dL
2.8 to 3.0 mmol/L
40 to 50 mg/dL
2.2 to 2.8 mmol/L
30 to 40 mg/dL
1.7 to 2.2 mmol/L
30 mg/dL
1.7 mmol/L
Hyperglycemia, Nonfasting 
and No Prior Diabetes
ULN to 160 mg/dL
160 to 250 mg/dL
250 to 500 mg/dL
500 mg/dL
ULN to 8.9 mmol/L
8.9 to 13.9 mmol/L
13.9 to 27.7 mmol/L
27.7 mmol/L
Hypocalcemia 
(corrected for albumin)
Adult and Pediatric
7 Days
7.8 mg/dL to LLN
7.0 to 7.8 mg/dL
6.1 to 7.0 mg/dL
6.1 mg/dL

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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
1.94 mmol/L to LLN
1.74 to 1.94 mmol/L
1.51 to 1.74 mmol/L
1.51 mmol/L
Infant, 7 Days
6.5 to 7.5 mg/dL
1.61 to 1.88  mmol/L
6.0 to 6.5 mg/dL
1.49 to < 1.61 mmol/L
5.5 to 6.0 mg/dL
1.36 to < 1.49 mmol/L
5.5 mg/dL
< 1.36 mmol/L
Hypercalcemia
(corrected for albumin)
Adult and Pediatric
7 Days
ULN to 11.5 mg/dL
11.5 to 12.5 mg/dL
12.5 to 13.5 mg/dL
13.5 mg/dL
ULN to 2.88 mmol/L
2.88 to 3.13 mmol/L
3.13 to 3.38 mmol/L
3.38 mmol/L
Infant, 7 Days
11.5 to 12.4 mg/dL
2.86 to 3.10  mmol/L
12.4 to 12.9 mg/dL
> 3.10 to 3.23  mmol/L
12.9 to 13.5 mg/dL
> 3.23 to 3.38  mmol/L
13.5 mg/dL
> 3.38 mmol/L
Hypocalcemia (ionized)
3.0 mg/dL to LLN
2.5 to < 3.0 mg/dL
2.0 to 2.5 mg/dL
2.0 mg/dL
0.74 mmol/L to LLN
0.62 to 0.74 mmol/L
0.49 to 0.62 mmol/L
0.49 mmol/L
Hypercalcemia (ionized)
ULN to 6.0 mg/dL
6.0 to 6.5 mg/dL
6.5 to 7.0 mg/dL
7.0 mg/dL
ULN to 1.50 mmol/L
1.50 to 1.63 mmol/L
1.63 to 1.75 mmol/L
1.75 mmol/L
Hypomagnesemia
1.45 mg/dL to LLN
1.09 to 1.45 mg/dL
0.72 to 1.09 mg/dL
0.72 mg/dL
0.60 mmol/L to LLN
0.45 to 0.60 mmol/L
0.30 to 0.45 mmol/L
0.30 mmol/L

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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypophosphatemia
Adult and Pediatric
14 Years
2.0 mg/dL to LLN
1.5 to 2.0 mg/dL
1.0 to 1.5 mg/dL
1.0 mg/dL
0.63 mmol/L to LLN
0.47 to 0.63 mmol/L
0.31 to 0.47 mmol/L
0.31 mmol/L
Pediatric 1 Year–14 
Years 
3.0 to 3.5 mg/dL
0.96 to 1.14 mmol/L
2.5 to 3.0 mg/dL
0.80 to < 0.96 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L
Pediatric 1 Year
3.5 to 4.5 mg/dL
1.12 to 1.46 mmol/L
2.5 to 3.5 mg/dL
0.80 to < 1.12 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L
Hyperbilirubinemia
Adult and Pediatric 
> 14 Days
1.0 to 1.5 ULN
1.5 to 2.5 ULN
2.5 to 5.0 ULN
5.0 ULN
Infant, 14 Days
(non-hemolytic)
NA
20.0 to 25.0 mg/dL
342 to 428 micromol/L
25.0 to 30.0 mg/dL
> 428 to 513 micromol/L
30.0 mg/dL
> 513 micromol/L
Infant, 14 Days
(hemolytic)
NA
NA
20.0 to 25.0 mg/dL
342 to 428 micromol/L
25.0 mg/dL
> 428 micromol/L
Blood Urea Nitrogen
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Hyperuricemia
ULN to 10.0 mg/dL
10.0 to 12.0 mg/dL
12.0 to 15.0 mg/dL
15.0 mg/dL
ULN to 597 micromol/L
597 to 716 micromol/L
716 to 895 micromol/L
895 micromol/L
Hypouricemia
1.5 mg/dL to LLN
1.0 to 1.5 mg/dL
0.5 to 1.0 mg/dL
0.5 mg/dL
90 micromol/L to LLN
60 to 90 micromol/L
30 to 60 micromol/L
30 micromol/L
Creatinine 
1.5 to 2.0 mg/dL
2.0 to 3.0 mg/dL
3.0 to 6.0 mg/dL
6.0 mg/dL

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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
137 to 181 micromol/L
181 to 269 micromol/L
269 to 535 micromol/L
535 micromol/L
Bicarbonate
16.0 mEq/L to LLN
11.0 to 16.0 mEq/L
8.0 to 11.0 mEq/L
8.0 mEq/L
16.0 mmol/L to LLN
11.0 to 16.0 mmol/L
8.0 to 11.0 mmol/L
8.0 mmol/L
Triglycerides
(Fasting)
—
500 to 750 mg/dL
750 to 1200 mg/dL
1200 mg/dL
5.64–8.47 mmol/L
8.47–13.55 mmol/L
13.55 mmol/L
Hypercholesterolemia
(Fasting)
200 to 239 mg/dL
239 to 300 mg/dL
300 mg/dL
—
5.16 to 6.19 mmol/L
6.19 to 7.77 mmol/L
7.77 mmol/L
Pediatric 18 Years
170 to 199 mg/dL
4.39 to 5.15 mmol/L
199 to 300 mg/dL
5.15 to 7.77 mmol/L
300 mg/dL
7.77 mmol/L
NA
Creatine Kinase
3.0 to 6.0 ULN
6.0 to 10.0 ULN
10.0 to 20.0 ULN
20.0 ULN
Lactate
ULN to 2.0 ULN without 
acidosis
2.0 ULN without acidosis
Increased lactate with pH 
7.3 without life-threatening 
consequences
Increased lactate with pH 
7.3 with life-threatening 
consequences

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ENZYMES
Grade 1
Grade 2
Grade 3
Grade 4
AST (SGOT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
ALT (SGPT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
GGT
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Alkaline Phosphatase 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Total Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Pancreatic Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Lipase 
1.0 to 1.5 ULN
1.5 to 3.0 ULN
3.0 to 5.0 ULN
5.0 ULN
Albumin
3.0 g/dL to LLN
2.0 to 3.0 g/dL
2.0 g/dL
—
30 g/L to LLN
20 to 30 g/L
20 g/L

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URINALYSIS
Grade 1
Grade 2
Grade 3
Grade 4
Hematuria (Dipstick) 
1
2
3+
NA
Hematuria (Quantitative) 
6–10 RBC/HPF
10 RBC/HPF
Gross, with or without clots 
OR with RBC casts
Transfusion indicated
Proteinuria (Dipstick)
1
2–3
4
NA
Proteinuria, 24 Hour 
Collection
Adult and Pediatric 
10 Years
200 to 999 mg/24 h
999 to 1999 mg/24 h
1999 to 3500 mg/24 h
3500 mg/24 h
Pediatric 3 Mo to 
< 10 Years
201 to 499 mg/m2/24 h
499 to 799 mg/m2/24 h
799 to 1000 mg/m2/24 h
1000 mg/ m2/24 h
Glycosuria (Dipstick)
1
2
3
4

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CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Cardiac Arrhythmia (general)
(By ECG or physical exam)
Asymptomatic AND No 
intervention indicated
Asymptomatic AND Non-
urgent medical intervention 
indicated
Symptomatic, non-life-
threatening AND Non-
urgent medical intervention 
indicated 
Life-threatening arrhythmia 
OR Urgent intervention 
indicated
Cardiac-ischemia/Infarction
NA
NA
Symptomatic ischemia 
(stable angina) OR Testing 
consistent with ischemia 
Unstable angina OR Acute 
myocardial infarction
Hemorrhage (significant 
acute blood loss)
NA
Symptomatic AND No 
transfusion indicated
Symptomatic AND 
Transfusion of 2 units 
packed RBCs (for children 
10 cc/kg) indicated 
Life-threatening hypotension 
OR Transfusion of 2 units 
packed RBCs indicated (for 
children 10 cc/kg) indicated
Hypertension (with repeat 
testing at same visit)
140–159 mmHg systolic 
OR 
90–99 mmHg diastolic
159–179 mmHg systolic 
OR 
99–109 mmHg diastolic
179 mmHg systolic 
OR 
109 mmHg diastolic
Life-threatening 
consequences (e.g., malignant 
hypertension) OR 
Hospitalization (other than 
ER visit) indicated
Pediatric 17 Years (with 
repeat testing at same visit)
NA
91st–94th percentile 
adjusted for age, height, and 
gender (systolic and/or 
diastolic)
≥95th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
Life-threatening 
consequences (e.g., malignant 
hypertension) OR 
Hospitalization indicated 
(other than emergency room 
visit)
Hypotension
NA
Symptomatic, corrected with 
oral fluid replacement
Symptomatic, IV fluids 
indicated
Shock requiring use of 
vasopressors or mechanical 
assistance to maintain blood 
pressure

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CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Pericardial Effusion
Asymptomatic, small 
effusion requiring no 
intervention
Asymptomatic, moderate or 
larger effusion requiring no 
intervention
Effusion with non-life-
threatening physiologic 
consequences OR Effusion 
with nonurgent intervention 
indicated
Life-threatening 
consequences (e.g., 
tamponade) OR Urgent 
intervention indicated
Prolonged PR Interval
PR interval 
0.21 to 0.25 sec
PR interval
0.25 sec
Type II 2nd degree AV 
block OR Ventricular pause 
3.0 sec
Complete AV block
Pediatric 16 Years
1st degree AV block
(PR > normal for age and 
rate)
Type I 2nd degree AV block
Type II 2nd degree AV 
block
Complete AV block
Prolonged QTc
Asymptomatic, QTc interval 
0.45 to 0.47 sec OR Increase 
interval 0.03 sec above 
baseline
Asymptomatic, QTc interval 
0.48 to 0.49 sec OR Increase 
in interval 0.03 to 0.05 sec 
above baseline
Asymptomatic, QTc 
interval 0.50 sec OR 
Increase in interval 
0.06 sec above baseline
Life-threatening 
consequences, e.g., Torsade 
de pointes or other associated 
serious ventricular 
dysrhythmia
Pediatric 16 Years
Asymptomatic, QTc interval 
0.450 to 0.464 sec
Asymptomatic, QTc interval 
0.465 to 0.479 sec
Asymptomatic, QTc 
interval 0.480 sec
Life-threatening 
consequences, e.g., Torsade 
de pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated 
(e.g., anticoagulation, lysis 
filter, invasive procedure)
Deep vein thrombosis AND 
Intervention indicated (e.g., 
anticoagulation, lysis filter, 
invasive procedure)
Embolic event (e.g., 
pulmonary embolism, life-
threatening thrombus)

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CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Vasovagal Episode 
(associated with a procedure 
of any kind)
Present without loss of 
consciousness
Present with transient loss of 
consciousness
NA
NA
Ventricular Dysfunction 
(congestive heart failure, 
CHF)
NA
Asymptomatic diagnostic 
finding AND intervention 
indicated
New onset with symptoms 
OR Worsening 
symptomatic CHF
Life-threatening CHF

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RESPIRATORY
Grade 1
Grade 2
Grade 3
Grade 4
Bronchospasm (acute)
FEV1 or peak flow reduced 
to 70% to 80%
FEV1 or peak flow 50% to 69%
FEV1 or peak flow 25% to 
49%
Cyanosis OR FEV1 or peak 
flow 25% OR Intubation
Dyspnea or 
Respiratory Distress
Dyspnea on exertion with no 
or minimal interference with 
usual social & functional 
activities
Dyspnea on exertion causing 
greater than minimal 
interference with usual social & 
functional activities
Dyspnea at rest causing 
inability to perform usual 
social & functional 
activities
Respiratory failure with 
ventilatory support indicated
Pediatric 14 Years
Wheezing OR minimal 
increase in respiratory rate for 
age
Nasal flaring OR Intercostal 
retractions OR Pulse oximetry 
90% to 95%
Dyspnea at rest causing 
inability to perform usual 
social & functional 
activities OR Pulse 
oximetry 90%
Respiratory failure with 
ventilatory support indicated
OCULAR/VISUAL
Grade 1
Grade 2
Grade 3
Grade 4
Uveitis
Asymptomatic but detectable 
on exam
Symptomatic anterior uveitis 
OR Medical intervention 
indicated
Posterior or pan-uveitis OR 
Operative intervention 
indicated
Disabling visual loss in affected
eye(s)
Visual Changes (from 
baseline)
Visual changes causing no or 
minimal interference with 
usual social & functional 
activities
Visual changes causing greater 
than minimal interference with 
usual social & functional 
activities
Visual changes causing 
inability to perform usual 
social & functional 
activities
Disabling visual loss in affected 
eye(s)

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SKIN
Grade 1
Grade 2
Grade 3
Grade 4
Alopecia
Thinning detectable by 
study participant or  
caregiver (for disabled 
adults)
Thinning or patchy hair loss 
detectable by health care 
provider
Complete hair loss
NA
Cutaneous Reaction – Rash
Localized macular rash 
Diffuse macular, 
maculopapular, or 
morbilliform rash OR Target 
lesions 
Diffuse macular, 
maculopapular, or 
morbilliform rash with vesicles 
or limited number of bullae 
OR Superficial ulcerations of 
mucous membrane limited to 
one site
Extensive or generalized 
bullous lesions OR 
Stevens-Johnson 
syndrome OR Ulceration 
of mucous membrane 
involving two or more 
distinct mucosal sites OR 
Toxic epidermal 
necrolysis (TEN)
Hyperpigmentation
Slight or localized
Marked or generalized
NA
NA
Hypopigmentation
Slight or localized 
Marked or generalized
NA
NA
Pruritis (itching – no skin 
lesions) 
(See also Injection Site 
Reactions: Pruritis associated 
with injection)
Itching causing no or 
minimal interference with 
usual social & functional 
activities
Itching causing greater than 
minimal interference with 
usual social & functional 
activities
Itching causing inability to 
perform usual social & 
functional activities 
NA

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GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Anorexia
Loss of appetite without 
decreased oral intake
Loss of appetite associated with 
decreased oral intake without 
significant weight loss 
Loss of appetite associated 
with significant weight loss 
Life-threatening 
consequences OR Aggressive 
intervention indicated [e.g., 
tube feeding or total 
parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND Intervention 
indicated (e.g., diuretics or 
therapeutic paracentesis)
Symptomatic despite 
intervention
Life-threatening 
consequences
Cholecystitis
NA
Symptomatic AND Medical 
intervention indicated
Radiologic, endoscopic, or 
operative intervention 
indicated
Life-threatening 
consequences (e.g., sepsis or 
perforation) 
Constipation 
NA
Persistent constipation requiring 
regular use of dietary 
modifications, laxatives, or 
enemas 
Obstipation with manual 
evacuation indicated
Life-threatening 
consequences (e.g., 
obstruction)
Diarrhea 
Adult and Pediatric 
1 Year
Transient or intermittent 
episodes of unformed 
stools OR Increase of 
3 stools over 
baseline/24 hr
Persistent episodes of unformed 
to watery stools OR Increase of 
4–6 stools over baseline per 
24 hrs. 
Bloody diarrhea OR Increase 
of 7 stools per 24-hour 
period OR IV fluid 
replacement indicated
Life-threatening 
consequences (e.g., 
hypotensive shock)
Pediatric 1 Year
Liquid stools (more 
unformed than usual) but 
usual number of stools
Liquid stools with increased 
number of stools OR Mild 
dehydration
Liquid stools with moderate 
dehydration
Liquid stools resulting in 
severe dehydration with 
aggressive rehydration 
indicated OR Hypotensive 
shock

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GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Dysphagia-Odynophagia 
Symptomatic but able to 
eat usual diet
Symptoms causing altered 
dietary intake without medical 
intervention indicated
Symptoms causing severely 
altered dietary intake with 
medical intervention 
indicated
Life-threatening reduction in 
oral intake
Mucositis/Stomatitis 
(clinical exam)
See also Proctitis, 
Dysphagia-Odynophagia
Erythema of the mucosa
Patchy pseudomembranes or 
ulcerations 
Confluent pseudomembranes 
or ulcerations OR Mucosal 
bleeding with minor trauma
Tissue necrosis OR Diffuse 
spontaneous mucosal 
bleeding OR Life-threatening 
consequences (e.g., 
aspiration, choking)
Nausea 
Transient (24 hours) or 
intermittent nausea with no 
or minimal interference 
with oral intake
Persistent nausea resulting in 
decreased oral intake for 24–48 
hours
Persistent nausea resulting in 
minimal oral intake for 48 
hours OR Aggressive 
rehydration indicated (e.g., 
IV fluids)
Life-threatening 
consequences (e.g., 
hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening 
consequences (e.g., sepsis, 
circulatory failure, 
hemorrhage)
Proctitis (functional-
symptomatic)
Also see Mucositis/ 
Stomatitis for Clinical 
Exam
Rectal discomfort AND No 
intervention indicated
Symptoms causing greater than 
minimal interference with usual 
social & functional activities 
OR Medical intervention 
indicated 
Symptoms causing inability 
to perform usual social/
functional activities OR 
Operative intervention 
indicated 
Life-threatening 
consequences (e.g., 
perforation)

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GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Vomiting
Transient or intermittent 
vomiting with no or 
minimal interference with 
oral intake
Frequent episodes of vomiting 
with no or mild dehydration
Persistent vomiting resulting 
in orthostatic hypotension OR 
Aggressive rehydration 
indicated
Life-threatening 
consequences (e.g., 
hypotensive shock)
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality-
Behavior or in Mood (e.g., 
agitation, anxiety, 
depression, mania, 
psychosis)
Alteration causing no or 
minimal interference with 
usual social & functional 
activities 
Alteration causing greater 
than minimal interference 
with usual social & functional 
activities 
Alteration causing inability to 
perform usual social & 
functional activities 
Behavior potentially harmful 
to self or others (e.g., 
suicidal/homicidal ideation or 
attempt, acute psychosis) OR 
Causing inability to perform 
basic self-care functions
Altered Mental Status 
For Dementia, see 
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and ADD)
Changes causing no or 
minimal interference with 
usual social & functional 
activities
Mild lethargy or somnolence 
causing greater than minimal 
interference with usual social 
& functional activities
Confusion, memory 
impairment, lethargy, or 
somnolence causing inability 
to perform usual social & 
functional activities
Delirium OR obtundation, 
OR coma
Ataxia 
Asymptomatic ataxia 
detectable on exam OR 
Minimal ataxia causing no 
or minimal interference 
with usual social & 
functional activities
Symptomatic ataxia causing 
greater than minimal 
interference with usual social 
& functional activities
Symptomatic ataxia causing 
inability to perform usual 
social & functional activities 
Disabling ataxia causing 
inability to perform basic 
self-care functions

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and Attention 
Deficit Disorder) 
Disability causing no or 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources not indicated
Disability causing greater 
than minimal interference 
with usual social & functional 
activities OR Specialized 
resources on part-time basis 
indicated
Disability causing inability to 
perform usual social & 
functional activities OR 
Specialized resources on a 
full-time basis indicated
Disability causing inability to 
perform basic self-care 
functions OR 
Institutionalization indicated
CNS Ischemia
(acute)
NA
NA
Transient ischemic attack
Cerebral vascular accident 
(CVA, stroke) with 
neurological deficit 
Developmental delay –
Pediatric 16 Years
Mild developmental delay, 
either motor or cognitive, 
as determined by 
comparison with a 
developmental screening
tool appropriate for the 
setting 
Moderate developmental 
delay, either motor or 
cognitive, as determined by 
comparison with a 
developmental screening tool 
appropriate for the setting 
Severe developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting 
Developmental regression, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting
Headache 
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater 
than minimal interference 
with usual social & functional 
activities
Symptoms causing inability 
to perform usual social & 
functional activities
Symptoms causing inability 
to perform basic self-care 
functions OR Hospitalization 
indicated (other than ER 
visit) OR Headache with 
significant impairment of 
alertness or other neurologic 
function 

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Insomnia
NA
Difficulty sleeping causing 
greater than minimal 
interference with usual 
social/functional activities
Difficulty sleeping causing 
inability to perform usual 
social & functional activities
Disabling insomnia causing 
inability to perform basic 
self-care functions
Neuromuscular Weakness 
(including myopathy & 
neuropathy) 
Asymptomatic with 
decreased strength on exam 
OR Minimal muscle weak-
ness causing no or minimal 
interference with usual 
social & functional 
activities
Muscle weakness causing 
greater than minimal 
interference with usual social 
& functional activities
Muscle weakness causing 
inability to perform usual 
social & functional activities 
Disabling muscle weakness 
causing inability to perform 
basic self-care functions OR 
Respiratory muscle weakness 
impairing ventilation
Neurosensory Alteration 
(including paresthesia and 
painful neuropathy)
Asymptomatic with 
sensory alteration on exam 
or minimal paresthesia 
causing no or minimal 
interference with usual 
social & functional 
activities 
Sensory alteration or 
paresthesia causing greater 
than minimal interference 
with usual social & functional 
activities 
Sensory alteration or 
paresthesia causing inability 
to perform usual social & 
functional activities
Disabling sensory alteration 
or paresthesia causing 
inability to perform basic 
self-care functions
Seizure: (new onset) 
NA
1 seizure 
2–4 seizures 
Seizures of any kind that are 
prolonged, repetitive (e.g., 
status epilepticus), or difficult 
to control (e.g., refractory 
epilepsy)

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Seizure: (pre-existing) 
For Worsening of Existing 
Epilepsy the Grades Should 
Be Based on an Increase 
from Previous Level of 
Control to Any of These 
Levels
NA
Increased frequency of pre-
existing seizures (non-
repetitive) without change in 
seizure character OR 
infrequent breakthrough 
seizures while on stable meds 
in a previously controlled 
seizure disorder
Change in seizure character 
from baseline either in 
duration or quality (e.g., 
severity or focality) 
Seizures of any kind that are 
prolonged, repetitive (e.g., 
status epilepticus), or difficult 
to control (e.g., refractory 
epilepsy)
Seizure 
– Pediatric 18 Years
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
< 5 minutes with 
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 5–20 
minutes with 
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
> 20 minutes 
Seizure, generalized onset 
with or without secondary 
generalization, requiring 
intubation and sedation
Syncope (not associated 
with a procedure)
NA
Present
NA
NA
Vertigo
Vertigo causing no or 
minimal interference with 
usual social & functional 
activities
Vertigo causing greater than 
minimal interference with 
usual social & functional 
activities 
Vertigo causing inability to 
perform usual social & 
functional activities
Disabling vertigo causing 
inability to perform basic 
self-care functions

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MUSCULOSKELETAL
Grade 1
Grade 2
Grade 3
Grade 4
Arthralgia
See also Arthritis
Joint pain causing no or 
minimal interference with 
usual social & functional 
activities
Joint pain causing greater than 
minimal interference with usual 
social & functional activities
Joint pain causing inability 
to perform usual social & 
functional activities
Disabling joint pain causing 
inability to perform basic 
self-care functions
Arthritis
See also Arthralgia
Stiffness or joint swelling 
causing no or minimal 
interference with usual 
social & functional 
activities
Stiffness or joint swelling causing 
greater than minimal interference 
with usual social & functional 
activities
Stiffness or joint swelling 
causing inability to perform 
usual social & functional 
activities
Disabling joint stiffness or 
swelling causing inability to 
perform basic self-care 
functions
Bone Mineral Loss
BMD t-score or z-score
–2.5 to –1.0 
BMD t-score or z-score –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Pediatric 21 Years
BMD z-score 
–2.5 to –1.0
BMD z-score < –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Myalgia
(non-injection site)
Muscle pain causing no or 
minimal interference with 
usual social & functional 
activities
Muscle pain causing greater than 
minimal interference with usual 
social & functional activities
Muscle pain causing 
inability to perform usual 
social & functional 
activities
Disabling muscle pain 
causing inability to perform 
basic self-care functions
Osteonecrosis
NA
Asymptomatic with radiographic 
findings AND No operative 
intervention indicated
Symptomatic bone pain 
with radiographic findings 
OR Operative intervention 
indicated
Disabling bone pain with 
radiographic findings causing 
inability to perform basic 
self-care functions

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SYSTEMIC
Grade 1
Grade 2
Grade 3
Grade 4
Acute Systemic Allergic 
Reaction 
Localized urticaria 
(wheals) with no medical 
intervention indicated
Localized urticaria with medical 
intervention indicated OR Mild 
angioedema with no medical 
intervention indicated
Generalized urticaria OR 
Angioedema with medical 
intervention indicated OR 
Symptomatic mild 
bronchospasm
Acute anaphylaxis OR Life-
threatening bronchospasm 
OR laryngeal edema
Chills
Symptoms causing no or 
minimal interference 
with usual social & 
functional activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities 
Symptoms causing inability 
to perform usual social & 
functional activities
NA
Fatigue
Malaise
Symptoms causing no or 
minimal interference 
with usual social & 
functional activities
Symptoms causing greater than
minimal interference with usual 
social & functional activities
Symptoms causing inability 
to perform usual social & 
functional activities
Incapacitating fatigue/malaise 
symptoms causing inability to 
perform basic self-care 
functions
Fever (nonaxillary)
37.7C to 38.6C
99.8F to 101.5F
38.7C to 39.3C
101.6F to 102.8F
39.4C to 40.5C
102.9F to 104.9F
40.5C 
104.9F
Pain- Indicate Body Site
See also Injection Site 
Pain, Headache, 
Arthralgia, and Myalgia
Pain causing no or 
minimal interference 
with usual social & 
functional activities
Pain causing greater than minimal 
interference with usual social & 
functional activities
Pain causing inability to 
perform usual social & 
functional activities
Disabling pain causing 
inability to perform basic 
self-care functions OR 
Hospitalization (other than 
ER visit) indicated
Unintentional Weight 
Loss
NA
5% to 9% loss in body weight 
from baseline
10% to 19% loss in body 
weight from baseline
20% loss in body weight 
from baseline OR  Aggressive 
intervention indicated [e.g., 
tube feeding or total 
parenteral nutrition]

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INJECTION SITE REACTION
Grade 1
Grade 2
Grade 3
Grade 4
Injection Site Pain (pain 
without touching)
Or Tenderness (pain when 
area is touched) 
Pain/tenderness causing no 
or minimal limitation of 
use of limb
Pain/tenderness limiting use 
of limb OR Pain/tenderness 
causing greater than minimal 
interference with usual social 
& functional activities
Pain/tenderness causing 
inability to perform usual
social & functional 
activities
Pain/tenderness causing 
inability to perform basic self-
care function OR 
Hospitalization (other than ER 
visit) indicated for management 
of pain/tenderness
Injection Site Reaction 
(Localized), 15 Years
Erythema OR Induration
of 5 5 cm to 9 9 cm (or 
2581 cm2)
Erythema OR Induration OR 
Edema 9 cm any diameter 
(or 81 cm2)
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR 
Drainage
Necrosis (involving dermis and 
deeper tissue)
Pediatric 15 Years
Erythema OR Induration 
OR Edema present but 
2.5 cm diameter
Erythema OR Induration OR 
Edema > 2.5 cm diameter but 
< 50% surface area of the 
extremity segment (e.g., 
upper arm/thigh)
Erythema OR Induration 
OR Edema involving 
50% surface area of the 
extremity segment (e.g., 
upper arm/thigh) OR 
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR 
Drainage
Necrosis (involving dermis and 
deeper tissue)
Pruritis Associated with 
Injection 
See also Skin: Pruritis 
(itching—no skin lesions)
Itching localized to 
injection site AND 
Relieved spontaneously or 
with 48 h treatment 
Itching beyond the injection 
site but not generalized OR 
Itching localized to injection 
site requiring 48 h 
treatment 
Generalized itching causing 
inability to perform usual 
social & functional 
activities
NA

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ENDOCRINE/METABOLIC
Grade 1
Grade 2
Grade 3
Grade 4
Lipodystrophy (e.g., back 
of neck, breasts, 
abdomen)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious 
changes on casual visual 
inspection
NA
Diabetes Mellitus
NA
New onset without need to initiate 
medication OR Modification of 
current meds to regain glucose 
control
New onset with initiation of 
indicated med OR Diabetes 
uncontrolled despite 
treatment modification
Life-threatening 
consequences (e.g., 
ketoacidosis, hyperosmolar 
non-ketotic coma) 
Gynecomastia
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA
Hyperthyroidism 
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid suppression therapy 
indicated
Symptoms causing inability 
to perform usual social & 
functional activities OR 
Uncontrolled despite 
treatment modification 
Life-threatening 
consequences (e.g., thyroid 
storm)
Hypothyroidism
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid replacement therapy 
indicated
Symptoms causing inability 
to perform usual social & 
functional activities OR 
Uncontrolled despite 
treatment modification 
Life-threatening 
consequences (e.g., 
myxedema coma)
Lipoatrophy (e.g., fat 
loss from the face, 
extremities, buttocks)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA

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GENITOURINARY
Grade 1
Grade 2
Grade 3
Grade 4
Intermenstrual 
Bleeding (IMB)
Spotting observed by 
participant OR Minimal blood 
observed during clinical or 
colposcopic exam
Intermenstrual bleeding not 
greater in duration or amount 
than usual menstrual cycle
Intermenstrual bleeding greater 
in duration or amount than 
usual menstrual cycle
Hemorrhage with life-
threatening hypotension 
OR Operative intervention 
indicated
Urinary Tract 
obstruction (e.g., 
stone)
NA
Signs or symptoms of urinary 
tract obstruction without 
hydronephrosis or renal 
dysfunction
Signs or symptoms of urinary 
tract obstruction with 
hydronephrosis or renal 
dysfunction
Obstruction causing life-
threatening consequences
INFECTION
Grade 1
Grade 2
Grade 3
Grade 4
Infection (any other 
than HIV infection)
Localized, no systemic
antimicrobial treatment 
indicated AND Symptoms 
causing no or minimal 
interference with usual social & 
functional activities
Systemic antimicrobial 
treatment indicated OR 
Symptoms causing greater 
than minimal interference 
with usual social & functional 
activities
Systemic antimicrobial 
treatment indicated AND 
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Operative intervention (other 
than simple incision and 
drainage) indicated
Life-threatening 
consequences (e.g., septic 
shock)
Basic Self-care Functions: Activities such as bathing, dressing, toileting, transfer/movement, continence, and feeding.
Usual Social & Functional Activities: Adaptive tasks and desirable activities, such as going to work, shopping, cooking, use of transportation, pursuing a hobby, etc.