An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Phase: PHASE4
Conditions: Lymphoid Malignancies
Sponsor: Gilead Sciences

Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
Gilead Study Director 
or Clinical Program 
Manager: 
Gilead Medical 
Monitor: 
(!') GILEAU 
CLINICAL STUDY PROTOCOL 
An Open Label, Roll Over Study to Provide Idelalisib to Subjects 
Previously Treated with the Investigational PI3Ko Inhibitor, GS-9820 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 
NIA 
2015-005766-39 
Lymphoid Malignancies 
GS-US-313-2120 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Fax: 
pp 
PPD 
t-'t-'U 
Lyndah Dreiling 
pp 
PPD 
Protocol Version/Date: 
Original: 05 Januaty 2016 
CONFIDENTIALITY STATEMENT 
The infonnation contained in this document, particularly unpublished data, is the property or 
under control 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 Board or Independent Ethics Committee. The infonnation is only to be used by you in 
com1ection with authorized clinical studies of the investigational dmg described in the protocol. 
You will not disclose any of the infonnation to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessaty to obtain infotmed 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........................................................................................................................................4
PROTOCOL SYNOPSIS ..............................................................................................................................................5
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS......................................................................8
1.
INTRODUCTION ................................................................................................................................................9
1.1.
Background ..............................................................................................................................................9
1.2.
Idelalisib...................................................................................................................................................9
1.3.
Rationale for This Study ........................................................................................................................10
1.4.
Benefit/Risk Assessment for the Study..................................................................................................10
1.5.
Compliance ............................................................................................................................................10
2.
OBJECTIVES.....................................................................................................................................................11
3.
STUDY DESIGN................................................................................................................................................12
3.1.
Endpoints ...............................................................................................................................................12
3.2.
Study Design..........................................................................................................................................12
3.3.
Study Treatments ...................................................................................................................................12
3.4.
Duration of Treatment............................................................................................................................12
3.5.
Discontinuation Criteria.........................................................................................................................12
3.6.
Source Data............................................................................................................................................13
3.7.
Biomarker Testing..................................................................................................................................13
4.
SUBJECT POPULATION..................................................................................................................................14
4.1.
Number of Subjects and Subject Selection ............................................................................................14
4.2.
Inclusion Criteria....................................................................................................................................14
4.3.
Exclusion Criteria...................................................................................................................................14
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................16
5.1.
Randomization, Blinding and Treatment Codes ....................................................................................16
5.2.
Description and Handling of Study Treatments .....................................................................................16
5.2.1.
Formulation..........................................................................................................................16
5.2.2.
Packaging and Labeling .......................................................................................................16
5.2.3.
Storage and Handling...........................................................................................................16
5.2.4.
Dosage and Administration of Idelalisib..............................................................................17
5.2.5.
Dispensing............................................................................................................................17
5.2.6.
Premedication.......................................................................................................................17
5.2.7.
Administration Instructions..................................................................................................17
5.2.8.
Dosing Schedule...................................................................................................................17
5.2.9.
Dose Levels..........................................................................................................................18
5.2.10.
Idelalisib Dose Adjustments.................................................................................................18
5.3.
Prior and Concomitant Medications.......................................................................................................19
5.3.1.
Anticancer or Experimental Therapies Other than Investigational 
Treatments............................................................................................................................20
5.3.2.
Antibiotics............................................................................................................................20
5.3.3.
Antidiarrheals.......................................................................................................................20
5.3.4.
Corticosteroids .....................................................................................................................20
5.3.5.
Granulocyte Colony-Stimulating Factors and Erythropoietin..............................................20
5.3.6.
Drugs that Alter CYP3A-Dependent Metabolism................................................................20
5.3.7.
Drugs that undergo CYP3A-Dependent Metabolism...........................................................21
5.3.8.
Immunization .......................................................................................................................21

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5.3.9.
Ultraviolet Exposure ............................................................................................................21
5.3.10.
Surgery .................................................................................................................................22
5.4.
Accountability for Idelalisib...................................................................................................................22
5.4.1.
Overdose Precautions...........................................................................................................22
5.4.2.
Inadvertent Exposure and Spill Precautions.........................................................................22
5.4.3.
Investigational Medicinal Product Return or Disposal.........................................................23
5.5.
Discontinuation from Study ...................................................................................................................23
6.
STUDY PROCEDURES ....................................................................................................................................24
6.1.
Subject Enrollment.................................................................................................................................24
6.1.1.
Subject Recruitment .............................................................................................................24
6.1.2.
Subject Compensation for Participation...............................................................................24
6.1.3.
Screening Visit .....................................................................................................................24
6.2.
Treatment Assessments..........................................................................................................................24
6.2.1.
Clinical Evaluation...............................................................................................................25
6.3.
End of Study...........................................................................................................................................25
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT...............................................................................27
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events.................................27
7.1.1.
Adverse Events.....................................................................................................................27
7.1.2.
Serious Adverse Events........................................................................................................27
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events .........................................................................28
7.2.
Assessment of Adverse Events and Serious Adverse Events.................................................................28
7.2.1.
Assessment of Causality for Idelalisib and Procedures........................................................28
7.2.2.
Assessment of Severity ........................................................................................................29
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead.......................................................................................................................29
7.3.1.
Serious Adverse Event (eSAE) Reporting Process ..............................................................30
7.4.
Gilead Reporting Requirements.............................................................................................................30
7.4.1.
Reporting of Adverse Events Relating and Other Anticipated Medical 
Events in the Study Population ............................................................................................31
7.4.2.
Toxicity Management...........................................................................................................31
7.5.
Special Situations Reports......................................................................................................................31
7.5.1.
Definitions of Special Situations..........................................................................................31
7.5.2.
Instructions for Reporting Special Situations.......................................................................32
8.
STATISTICAL CONSIDERATIONS................................................................................................................34
8.1.
Analysis Objectives................................................................................................................................34
8.2.
Safety Endpoints ....................................................................................................................................34
8.3.
Analysis Sets..........................................................................................................................................34
8.4.
Analysis Methods...................................................................................................................................34
8.5.
Adverse Events.......................................................................................................................................34
9.
RESPONSIBILITIES..........................................................................................................................................35
9.1.
Investigator Responsibilities ..................................................................................................................35
9.1.1.
Good Clinical Practice..........................................................................................................35
9.1.2.
Independent Ethics Committee (IEC) Review and Approval...............................................35
9.1.3.
Informed Consent.................................................................................................................35
9.1.4.
Confidentiality......................................................................................................................36
9.1.5.
Study Files and Retention of Records ..................................................................................36
9.1.6.
Case Report Forms...............................................................................................................37
9.1.7.
Drug Accountability and Return ..........................................................................................38
9.1.8.
Inspections............................................................................................................................38

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9.1.9.
Protocol Compliance............................................................................................................38
9.2.
Sponsor Responsibilities ........................................................................................................................38
9.2.1.
Protocol Modifications.........................................................................................................38
9.2.2.
Communications with Regulatory Authorities.....................................................................39
9.2.3.
Study Report and Publications .............................................................................................39
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................39
9.3.1.
Payment Reporting...............................................................................................................39
9.3.2.
Access to Information for Monitoring..................................................................................40
9.3.3.
Access to Information for Auditing or Inspections ..............................................................40
9.3.4.
Study Discontinuation..........................................................................................................40
10.
REFERENCES ...................................................................................................................................................41
11.
APPENDICES ....................................................................................................................................................44
Appendix 1.
Investigator Signature Page....................................................................................................45
Appendix 2.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements...................................................................................................46
LIST OF IN-TEXT TABLES
Table 5-1.
Idelalisib Dose Levels ............................................................................................................18
Table 5-2.
Dose Adjustment Guidelines {Gilead Sciences Inc 2014}.....................................................19
Table 6-1.
Schedule of Study Procedures................................................................................................26
Table 7-1.
Grading of Adverse Event Severity........................................................................................29

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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
199 East Blaine Street
Seattle, WA 98102
Study Title: 
An Open Label, Roll Over Study to Provide Idelalisib to Subjects 
Previously Treated with the Investigational PI3Kδ Inhibitor, GS-9820
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
Not Applicable
2015-005766-39
Study Centers 
Planned:
2 centers in the Netherlands
Objectives:
The primary objective of this study is as follows:

To provide open-label idelalisib to subjects receiving GS-9820 in 
Study GS-US-315-0102 at the time of study closure who have had
objective evidence of clinical benefit defined as at least stable 
disease on imaging assessed by an independent review committee 
(IRC) and no toxicities prior to enrollment in this study that 
would preclude initiating therapy with idelalisib. Idelalisib and 
GS-9820 are both in the class of agents that inhibit PI3Kδ and as 
such this exchange of class for class agent is warranted and 
acceptable.
Study Design:
This study is an open-label, rollover study to provide idelalisib to 
subjects receiving GS-9820 in Study GS-US-315-0102 at the time of 
study closure.
Number of Subjects 
Planned:
Approximately 6 subjects
Target Population:
Subjects receiving GS-9820 in Study GS-US-315-0102 at the time of 
study closure who have objective evidence of clinical benefit defined 
as at least stable disease on imaging assessed by the IRC at final 
response assessment prior to enrollment in this study.
Duration of 
Treatment:
Subjects will be treated until progressive disease or intolerable 
toxicity.

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Diagnosis and Main 
Eligibility Criteria:
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be 
eligible for participation in this study:
1) Receiving GS-9820 in Study GS-US-315-0102 with objective 
evidence of clinical benefit defined as at least stable disease on 
imaging assessed by the IRC at the time of Study 
GS-US-315-0102 closure
2) For female subjects of childbearing potential, willingness to use a 
protocol recommended method of contraception during 
heterosexual intercourse from the signing of informed consent 
throughout the study treatment period and up to 30 days from the 
last dose of idelalisib (see Appendix 2)
3) For male subjects of reproductive potential having intercourse 
with females of childbearing potential, willing to use a protocol 
recommended method of contraception during heterosexual 
intercourse and to refrain from sperm donation throughout the 
study treatment period and for 90 days following discontinuation 
of idelalisib (see Appendix 2)
4) Willingness to comply with scheduled visits, drug administration 
plan, imaging studies, laboratory tests, other study procedures, 
and study restrictions. Note: Psychological, social, familial, or 
geographical factors that might preclude adequate study 
participation should be considered.
5) Evidence of a personally signed informed consent indicating that 
the subject is aware of the neoplastic nature of their disease and 
has been informed of the procedures to be followed, the 
experimental nature of the therapy, alternatives, potential benefits, 
possible side effects, potential risks and discomforts, and other 
pertinent aspects of study participation.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not
eligible to be enrolled in this study:
1) Known hypersensitivity or intolerance to any of the active 
substances or excipients in the formulation of idelalisib.
2) Toxicities that would preclude initiating therapy with idelalisib 
prior to enrollment (eg, history of drug-induced pneumonitis, 
ongoing inflammatory bowel disease)
3) Concurrent participation in another therapeutic clinical trial.
4) Pregnant or breastfeeding

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Study Procedures/
Frequency:
All subjects will receive idelalisib 150 mg taken orally, twice per day 
(BID) continuously. Subjects will undergo disease assessments and 
receive medical care per institutional standards of care.
Test Product, Dose, 
and Mode of 
Administration:
Idelalisib: 150 mg taken orally BID starting on Day 1 and 
administered continuously thereafter.
Reference Therapy, 
Dose, and Mode of 
Administration:
None
Criteria for 
Evaluation:
Safety:
Overall safety profile characterized by the type, frequency, severity, 
timing of onset, duration, and relationship to study therapy of ≥Grade 
3 adverse events (AEs), serious adverse events (SAEs), and deaths.
Efficacy:
Investigator response assessments
Statistical Methods:
Safety will be assessed by incidence of ≥ Grade 3 AEs, SAEs, and 
deaths. Efficacy will be evaluated by investigator response 
assessments. Both safety and efficacy will be assessed using data 
collected from subjects who received at least 1 dose of idelalisib. All 
analyses will be limited to descriptive summaries and listings.
Sample Size:
Up to 6 subjects
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
AE
adverse event
ALT
alanine aminotransferase
ANC
absolute neutrophil count
AST
aspartate aminotransferase
AUC
area under the concentration versus time curve
-HCG
beta human chorionic gonadotropin
BID
bis in die (twice daily)
CFR
Code of Federal Regulations
CLL
chronic lymphocytic leukemia
CRO
contract research organization
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CYP
cytochrome P450
DSPH
Drug Safety and Public Health
eCRF
electronic case report form
EOS
end of study
EU
European Union
FDA
Food and Drug Administration
FSH
follicle stimulating hormone
G-CSF
granulocyte colony-stimulating factor
GCP
good clinical practice
GM-CSF
granulocyte-macrophage colony-stimulating factors
HLT
High-Level Term
HMG-CoA
3-hydroxy-3-methyl-glutaryl-Coenzyme A
IB
investigator’s brochure
ICH
International Conference on Harmonisation
iNHL
indolent non-Hodgkin lymphoma
IEC
independent ethics committee
IUD
intrauterine device
MCL
mantle cell lymphoma
NHL
non-Hodgkin lymphoma
PI3K
phosphatidylinositol 3-kinase
PDE5
phosphodiesterase-5
SAE
serious adverse event
SOC
system organ class
SOP
standard operating procedure
SADR
serious adverse drug reaction
SUSAR
suspected unexpected serious adverse reactions
ULN
upper limit of normal

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1.
INTRODUCTION
1.1.
Background
B-cell lymphoid malignancies comprise the most common hematological malignancies 
{Surveillance Epidemiology and End Results (SEER) Program 2011}. These cancers arise from 
the accumulation of monoclonal B lymphocytes in lymph nodes and often in organs such as 
blood, bone marrow, lymph nodes, spleen, and liver. Among the variants of these cancers are 
non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL), indolent 
non Hodgkin lymphoma (iNHL), and mantle cell lymphoma (MCL), as well as chronic 
lymphocytic leukemia (CLL) and Hodgkin lymphoma (HL). These disorders are characterized 
by lymphadenopathy that is frequently disturbing for patients and can sometimes induce life 
threatening organ dysfunction; patients may also have constitutional symptoms (fevers, night 
sweats, and/or weight loss) and fatigue {Diehl et al 2004}, {Salles 2007}, {Dighiero et al 2008}, 
{Williams et al 2010}. 
The goal of therapy for these diseases is to induce tumor regression and delay tumor progression 
in order to control disease-related complications and potentially extend life. Patients who require 
treatment are commonly given chemotherapeutic and/or immunotherapeutic agents {Hoppe et al 
2008}, {Jost 2007} {Eichhorst et al 2010}, {Friedberg 2011}, {Gribben et al 2011}, {Zelenetz et 
al 2011}. Among patients with iNHL, CLL, and MCL, front line combination therapies can be 
effective in providing durable remissions {Lenz et al 2005}, {Santoro et al 1987}, {Schulz et al 
2007}, {Hallek et al 2010}, {Recher et al 2011}. In DLBCL and HL, such front-line regimens 
can be curative in the majority of patients {Santoro et al 1987}, {Kuruvilla 2009}, {Recher et al 
2011}. However, most treated patients with iNHL, CLL, and MCL will eventually experience 
disease relapse. Some patients with DLBCL or HL will experience recurrent disease even with 
initial induction therapy and later salvage therapy. For any of these cancers, further sequential 
therapies are given in an attempt to control disease manifestations. Despite use of agents with 
differing mechanisms of action, progressive resistance to treatment develops. Patients with 
progressive disease have a poor prognosis; median survival for these groups of patients is 
generally ≤2 years {Keating et al 2002}, {Goy et al 2009}, {Hess et al 2009}, {Moskowitz et al 
2009}, {Di Bella et al 2010}, {Wierda et al 2010}, {Friedberg 2011}. Novel mechanisms of 
action are needed to offer additional treatment options for patients with lymphoid malignancies 
who are experiencing progressive lymphadenopathy or symptoms due to disease progression.
1.2.
Idelalisib
Idelalisib (Zydelig®) was first approved in the United States on July 23, 2014 for the treatment 
of relapsed CLL, follicular lymphoma (FL), and small lymphocytic lymphoma (SLL), followed 
by approval in the EU on September 18, 2014 (centrally authorized). To date, Zydelig is 
currently approved in 37 countries. Refer to local labeling for the approved indication 
statements.

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Idelalisib is a potent competitive inhibitor of the adenosine triphosphate (ATP) binding site of 
the phosphatidylinositol 3 kinase (PI3K) p110δ catalytic domain, which has been shown to be 
prominently expressed in cells of hematopoietic origin {Okkenhaug et al 2003}, 
{Vanhaesebroeck et al 2005}. The effects of p110δ on lymphocyte activation/function, cellular 
proliferation, and protection from apoptosis provide the rationale for targeting this isoform as a 
therapy for hematologic malignancies.
Further details on the preclinical pharmacology, toxicology, metabolism and pharmacokinetics 
(PK) of idelalisib can be found in the idelalisib Investigator’s Brochure (IB).
1.3.
Rationale for This Study
Study GS-US-315-0102 is being conducted to evaluate the safety and efficacy of GS-9820, a 
second generation PI3Kδ inhibitor in subjects with iNHL, DLBCL, MCL, HL, or CLL. GS-9820 
was anticipated to offer similar efficacy to idelalisib in lymphoid malignancies while offering a 
more favorable safety profile than idelalisib. The development of GS-9820 has been 
discontinued by Gilead Sciences due to demonstration of a similar safety profile to idelalisib. 
Manufacture of the investigational agent GS-9820 has been discontinued, and will no longer be 
available to the ongoing subjects in Study GS-US-315-0102.  
This rollover study provides access to idelalisib for eligible subjects receiving GS-9820 in Study 
GS-US-315-0102 at the time of study closure who have had objective evidence of clinical benefit 
defined as at least stable disease on imaging assessed by the independent review committee 
(IRC) and no toxicities prior to enrollment in this study that would preclude initiating therapy 
with idelalisib.  Subjects will be allowed to receive treatment on this study until unacceptable 
toxicity, progressive disease, study withdrawal, or death occurs.
1.4.
Benefit/Risk Assessment for the Study
Subjects enrolled in this study have a serious life-threatening disease, with limited treatment 
options. Without treatment their disease will progress and ultimately be fatal. Transitioning 
subjects from GS-9820 to idelalisib, a similar agent in class that has shown proof of clinical 
activity and has received regulatory approval for the treatment of relapsed CLL and iNHL 
{Gilead Sciences Limited 2015}, is rational as described in Section 1.3 of this protocol; 
therefore, subjects enrolled in this study may derive clinical benefit defined as an improvement 
in disease control such as response to study treatment. The risks that may accompany study 
treatment are related to the identified and potential toxicities of treatment with idelalisib and are 
described in Section 5 of this protocol and in the ICF. The management of these toxicities is 
described in Table 5-2. Taken together, there is a positive benefit/risk for initiating study 
treatment with idelalisib in subjects previously treated with GS-9820.
1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.

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2.
OBJECTIVES
The primary objective of this study is:

To provide idelalisib, a marketed PI3Kδ inhibitor, in lieu of GS-9820, an investigational 
second generation PI3Kδ inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102
at the time of study closure who have had objective evidence of clinical benefit defined as at 
least stable disease on imaging assessed by the IRC and no toxicities prior to enrollment in 
this study that would preclude initiating therapy with idelalisib. Idelalisib and GS-9820 are 
both in the class of agents that inhibit PI3Kδ and as such this exchange of class for class 
agent is warranted and acceptable.

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3.
STUDY DESIGN
3.1.
Endpoints
There is no primary endpoint of this study.
3.2.
Study Design
This study is an open-label, rollover study to provide idelalisib to subjects receiving GS-9820 in 
Study GS-US-315-0102 at the time of study closure.
3.3.
Study Treatments
All subjects will receive idelalisib 150 mg taken orally, twice per day (BID) continuously. 
3.4.
Duration of Treatment
Treatment will continue until unacceptable toxicity, disease progression, study discontinuation 
(outlined below), or death occurs.
3.5.
Discontinuation Criteria
A subject may be withdrawn from the study under the following circumstances:

The subject withdraws consent to participate in the study

The subject permanently discontinues idelalisib treatment for any reason

The subject experiences a toxicity that necessitates permanent discontinuation of idelalisib
treatment

The subject has progressive disease 

The subject does not comply with the requirements of the protocol (eg initiation of a 
non-protocol anti-tumor treatment)

Gilead, a regulatory agency, or an independent ethics committee (IEC) discontinues the study
The reason for withdrawal will be recorded in the eCRF.

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3.6.
Source Data
Electronic data (ie, diagnostic machines that transcribe data directly to a database, or data entered 
directly into an Electronic Medical Record system) is considered source data, provided the data 
is not recorded directly on the CRF/eCRF, and provided there is a clear audit trail in the 
electronic record(s). No data will be recorded directly on the CRF/eCRF, and any data recorded 
directly on the CRF/eCRF will not be considered source data.
3.7.
Biomarker Testing
There will be no biomarker testing in this study.

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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
Approximately 6 subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study 
closure are anticipated.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study:
1) Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit 
defined as at least stable disease on imaging assessed by the IRC at the time of Study 
GS-US-315-0102 closure
2) For female subjects of childbearing potential, willingness to use a protocol recommended 
method of contraception during heterosexual intercourse from the signing of informed 
consent throughout the study treatment period and up to 30 days from the last dose of 
idelalisib (see Appendix 2)
3) For male subjects of reproductive potential having intercourse with females of childbearing 
potential, willing to use a protocol recommended method of contraception during 
heterosexual intercourse and to refrain from sperm donation throughout the study treatment 
period and for 90 days following discontinuation of idelalisib (see Appendix 2)
4) Willingness to comply with scheduled visits, drug administration plan, imaging studies, 
laboratory tests, other study procedures, and study restrictions. Note: Psychological, social, 
familial, or geographical factors that might preclude adequate study participation should be 
considered.
5) Evidence of a personally signed informed consent indicating that the subject is aware of the 
neoplastic nature  of their disease and has been informed of the procedures to be followed, 
the experimental nature of the therapy , alternatives, potential benefits, possible side effects, 
potential risks and discomforts, and other pertinent aspects of study participation.
4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not eligible to be enrolled in this 
study:
1) Known hypersensitivity or intolerance to any of the active substances or excipients in the 
formulation of idelalisib.

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2) Toxicities that would preclude initiating therapy with idelalisib prior to enrollment
(eg history of drug-induced pneumonitis, ongoing inflammatory bowel disease)
3) Concurrent participation in another therapeutic clinical trial.
4) Pregnant or breastfeeding.

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5. 
INVESTIGATIONAL MEDICINAL PRODUCTS 
5.1. 
Randomization, Blinding and Treatment Codes 
The study is open-label and non-randomized. 
5.2. 
Description and Handling of Study Treatments 
5.2.1. 
Formulation 
Final 
Original 
Idelalisib 150 mg tablets are pink, oval-shaped and debossed with ' 'GSI' ' on one side and 
" 150" on the other. The 100 mg tablets are orange, oval-shaped and debossed with " GSI" on 
one side and " 1 00" on the other. All tablets are film-coated, and include the followina inactive 
exci ients: PD 
5.2.2. 
Packaging and Labeling 
Idelalisib tablets, 150 mg or 100 mg, are packaged in white, high density polyethylene (HDPE) 
bottles. Each bottle contains 60 tablets and polyester packing material. Each bottle is enclosed 
with a white, continuous thread, child-resistant polypropylene screw cap with an induction-
sealed and alumimun-faced liner. 
Idelalisib to be distributed to centers in the US and other pruticipating cmmtries shall be labeled 
to meet applicable requirements of the United States Food and Dmg Administration (FDA), EU 
Guideline to Good Manufacturing Practice - Annex 13 (Investigational Medicinal Products), 
and/or other local regulations. 
5.2.3. 
Storage and Handling 
Idelalisib should be stored at controlled room temperature of 25°C (77°F); excursious ru·e 
permitted between 15°C and 30°C (59°F and 86°F). Storage conditions are specified on the 
label. Until dispensed to the subjects, all bottles of study <hugs should be stored in a securely 
locked ru·ea, accessible only to authorized site personnel. 
To ensure the stability and proper identification, study <hug should not be stored in a container 
other than the container in which they were supplied. Consideration should be given to handling, 
preparation, and disposal through measures that minimize <h·ug contact with the body. 
Appropriate precautions should be followed to avoid direct eye contact or exposure when 
handling. 
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5.2.4.
Dosage and Administration of Idelalisib
Idelalisib formulated drug product of 100 and 150 mg strengths has been manufactured for 
clinical trials and will be provided to the subject to be taken at home. Subjects should be 
instructed to take the doses with water. Idelalisib may be taken with or without food. Missed 
doses should not be taken unless it is within 6 hours of the scheduled dosing and vomited doses 
should be retaken only if the tablet is visible in the vomitus.
Idelalisib will be taken twice daily. Idelalisib should be taken at approximately the same times 
each day. Ideally, doses should be taken at approximately 12 hour intervals as instructed 
(eg, at 7 AM and at 7 PM). While it is realized that variations in dosing schedule may occur in 
the outpatient setting, the prescribed regimen should be followed as closely as possible.
5.2.5.
Dispensing
The clinic staff (eg, pharmacist or other qualified person) will be responsible for dispensing 
idelalisib. It is planned that idelalisib will be dispensed at 4-week intervals through the 
first 16 weeks of treatment, at 8-weeks, and at 12-week intervals thereafter. Sufficient idelalisib
will be provided for each study period at the beginning of the period. Tablets should be 
dispensed in the original bottles provided.
The clinic staff (eg, pharmacist or other qualified person) will write the subject number on each 
bottle that is dispensed. Immediately before dispensing, the clinic staff will write the bottle 
number for each dispensed bottle in the idelalisib administration record corresponding to the 
subject number.
5.2.6.
Premedication
No specific pre-medications or supporting medications are required in conjunction with idelalisib
administration.
5.2.7.
Administration Instructions
The prescribed dose of idelalisib should be taken orally. At each dose administration, the tablet 
number corresponding to the appropriate dose of idelalisib is to be swallowed whole with 
100 to 200 mL (~4 to 8 ounces) of water. In case of breakage of the tablets in the oral cavity, 
additional water should be taken as a rinse.
Idelalisib may be taken with or without food. There are no known dietary restrictions related to 
idelalisib use.
5.2.8.
Dosing Schedule
Idelalisib will be administered on a BID schedule. Idelalisib should be taken at approximately the 
same times each day.

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5.2.9.
Dose Levels
Idelalisib dose levels are shown in Table 5-1. The starting dose level will be 150 mg BID. The 
lower dose level (Dose Level -1) is provided in case a subject requires a dose modification.
Table 5-1.
Idelalisib Dose Levels
Dose Level
Dosing Regimen
Starting
150 mg BID
-1
100 mg BID
Abbreviation: BID=twice per day
Consistent with Table 5-2, if a subject experiences an AE that is suspected to be related to 
idelalisib during the course of study, idelalisib administration may be held, as necessary, until the 
AE resolves or stabilizes to an acceptable degree (as defined in Table 5-2). Thereafter, idelalisib 
may be reinitiated at either the Starting Dose Level or at Dose Level -1 consistent with the 
instructions in Section 5.2.10. A further attempt at reinitiation of therapy at Dose Level -1 may 
be attempted if the investigator feels that a second rechallenge at that dose level is medically 
appropriate. If the subject cannot tolerate idelalisib after 2 rechallenges at Dose Level -1 for the 
same AE, then the subject should be discontinued from idelalisib treatment.
After an idelalisib dose reduction, the dose need not be re-escalated, even if there is minimal or 
no toxicity with the reduced dose. However, if the subject tolerates Dose Level -1 of idelalisib
for 4 weeks, then the dose may be increased back to Starting Dose Level, at the discretion of 
the investigator. Such a re-escalation may be particularly warranted if further evaluation reveals 
that the AE that led to the dose reduction was not related to idelalisib.
5.2.10.
Idelalisib Dose Adjustments
The dose adjustment recommendations in Table 5-2 are based on the Common Terminology 
Criteria for Adverse Events (CTCAE) grade of specific toxicities. However, exceptions are 
expected for subjects who initiate study treatment with low blood counts. Clinical judgment 
should apply, and in cases of uncertainty, the study medical monitor should be contacted.
The dose modification instructions focus on the types of events most commonly attributed to 
idelalisib. The recommendations provided in Table 5-2 comprise only guidelines; variations from 
these recommendations may be warranted based on an investigator’s individual judgment in 
considering potential risks, benefits, and therapeutic alternatives available to each subject.

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Table 5-2.
Dose Adjustment Guidelines {Gilead Sciences Inc 2014}
Pneumonitis
Any symptomatic pneumonitis
Discontinue Zydelig in subjects with any severity of symptomatic pneumonitis
ALT/AST
>3-5 x ULN
>5-20 x ULN
>20 x ULN
Maintain idelalisib dose. 
Monitor at least weekly 
until <1 x ULN.
Withhold idelalisib.
Monitor at least weekly until 
ALT/AST are <1 x ULN, 
then may resume idelalisib at 
100 mg BID.
Discontinue idelalisib 
permanently.
Bilirubin
>1.5-3 x ULN
>3-10 x ULN
>10 x ULN
Maintain idelalisib dose. 
Monitor at least weekly 
until <1 x ULN.
Withhold idelalisib. 
Monitor at least weekly 
until bilirubin is <1 x ULN, 
then may resume idelalisib 
at 100 mg BID.
Discontinue idelalisib 
permanently.
Diarrhea
Moderate diarrhea
Severe diarrhea or 
hospitalization
Life-threatening diarrhea
Maintain idelalisib dose. 
Monitor at least weekly 
until resolved.
Withhold idelalisib. 
Monitor at least weekly 
until resolved, then may 
resume idelalisib at 100 mg 
BID.
Discontinue idelalisib 
permanently.
Neutropenia
ANC 1.0 to <1.5 Gi/L
ANC 0.5 to <1.0 Gi/L
ANC <0.5 Gi/L
Maintain idelalisib dose.
Maintain idelalisib dose. 
Monitor ANC at least 
weekly.
Interrupt idelalisib. Monitor 
ANC at least weekly until 
ANC ≥0.5 Gi/L, then may 
resume idelalisib at 100 mg 
BID.
Thrombocytopenia
Platelets 50 to <75 Gi/L
Platelets 25 to <50 Gi/L
Platelets <25 Gi/L
Maintain idelalisib dose.
Maintain idelalisib dose. 
Monitor platelet counts at 
least weekly.
Interrupt idelalisib. Monitor 
platelet count at least weekly. 
May resume idelalisib at 
100 mg BID when platelets 
≥25 Gi/L.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; ULN, upper limit of normal
5.3.
Prior and Concomitant Medications
If considered necessary for the subject’s well-being, drugs for concomitant medical conditions or 
for symptom management may be given at the discretion of the investigator.

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Any concomitant medications prescribed as a therapeutic intervention for or resulting in an AE 
or SAE during the course of the study and the reason for use should be recorded on the eCRFs. 
5.3.1. 
Anticancer or Experimental Therapies Other than Investigational 
Treatments 
Except for corticosteroids, no other anticancer therapies (including chemotherapy, radiation, 
antibody therapy, immunotherapy, or other experimental therapies) of any kind are permitted. 
Subjects are not allowed to participate concurrently in any other therapeutic clinical study. 
5.3.2. 
Antibiotics 
Except in a subject who has a contra-indication, investigators should consider initiation of 
antibiotic prophylaxis against pneumocystis infection ( eg, with trimethoprim-sulfamethoxazole, 
dapsone, aerosolized pentamidine, or atovaquone) beginning prior to idelalisib administration. 
Investigator discretion and local practices or guidelines may be followed. 
For subjects who develop an infection, appropriate medical therapy (with antibiotics, antifungals, 
or antiviral) or other interventions should be instituted. Whenever appropriate, subjects may 
continue with idelalisib during treatment for the infection. 
5.3.3. 
Antidiarrheals 
As needed, subjects may be prescribed loperamide (Imodium® or others) or diphenoxylate and 
atropine (Lomotil®) to control diarrheal symptoms. 
5.3.4. 
Corticosteroids 
Subjects may receive topical, inhaled, enteric, or systemic corticosteroids while on study. 
5.3.5. 
Granulocyte Colony-Stimulating Factors and Erythropoietin 
Granulocyte-macrophage colony-stimulating factor (GM-CSF) should not be administered given 
the potential for GM-CSF-related inflammatory symptoms. 
G-CSF (filgrastim, PEG-filgrastim, lenograstim) may be administered in response to 
Grade 4 neutropenia or neutropenic complications; (see Table 5-2). 
While erythropoietic agents (eg, erythropoietin or darbepoetin) may be administered for 
Grade ~3 anemia, their use in this study is discouraged given the potential to confound 
assessments of improvements in bone marrow function related to idelalisib. 
5.3.6. 
Drugs that Alter CYP3A-Dependent Metabolism 
Idelalisib is metabolized to its major metabolite -PO 
via aldehyde oxidase and 
cytochrome P450 3A (CYP3A). Idelalisib also undergoes minor metabolism by UDP 
glucoronosyltransferase 1-4 (UGT1A4). The AUC ofidelalisib was increased 1.8 fold when 
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idelalisib was coadministered with a strong CYP3A inhibitor. Therefore, if subjects are taking 
concomitant strong CYP3A inhibitors, the subject should be monitored closely for signs of 
idelalisib toxicity and the dose modifications for adverse reactions should be followed in the 
event of toxicity (see Table 5-2). 
Additionally, idelalisib exposures are approximately 75% lower when coadministered with 
rifampin, a highly potent inducer of CYP3A. Therefore, avoid coadministration of strong 
inducers ofCYP3A (rifampin, carbamazepine, phenytoin, and St. John's wort) with idelalisib. 
5.3.7. 
Drugs that undergo CYP3A-Dependent Metabolism 
The major metabolite of idelalisib, PPD 
is a reversible and time dependent inhibitor of 
CYP3A; accordingly, coadministration of idelalisib with midazolam, a probe CYP3A substrate, 
resulted in a ~5-fold increase in midazolam systemic exposure (AUC). Coadministration of 
drugs that are narrow therapeutic index CYP3A substrates with idelalisib may result in an 
increase in their systemic exposures ( eg, antiarrhythmics, calcium channel blockers, 
benzodiazepines, certain HMG-CoA reductase inhibitors, phosphodiesterase-S [PDE5] 
inhibitors, warfarin). Avoid coadministration of drugs that are narrow therapeutic index CYP3A 
substrates ( eg, alfentanil, cyclosporine, sirolimus, tacrolimus, cisapride, pimozide, fentanyl, 
quinidine, ergotamine, dihydroergotamine, astemizole, terfenadine) with idelalisib. 
5.3.8. 
Immunization 
Because of its actions to inhibit PI3K8-dependent B-cell function, high doses of idelalisib can 
impair primary or secondary responses to immunization in animals. 
The specific clinical relevance ofthese findings with idelalisib is unknown. However, for 
subjects who are at substantial risk of an infection ( eg, influenza) that might be prevented by 
immunization, consideration should be given to providing the vaccine prior to initiation of study 
therapy. 
Of note, the safety of immunization with live viral vaccines following idelalisib therapy has not 
been studied and vaccination with live virus vaccines during study treatment is not 
recommended. 
5.3.9. 
Ultraviolet Exposure 
While nonclinical findings suggest the hypothetical potential for phototoxicity in humans, 
available clinical data do not reveal a photosafety concern. Although specific clinical correlates 
for these nonclinical data are not available, investigators and study subjects should be observant 
for the possibility that study participants may have exaggerated sunburn reactions ( eg, burning, 
erythema, exudation, vesicles, blistering, edema) involving areas of skin exposed to ultraviolet 
light. 
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5.3.10.
Surgery
There are no known effects of idelalisib on coagulation or wound healing. Pending receipt of 
additional information and considering the subject’s current platelet counts, idelalisib may be 
continued in the peri-procedural period in subjects who require surgery or invasive procedures.
5.4.
Accountability for Idelalisib
The disposition of all idelalisib should be documented from the time of receipt at the site through 
subject dispensing and return.
Study personnel must ensure that idelalisib is kept in a secure locked area with access limited to 
authorized personnel. The idelalisib must not be used outside the context of this protocol. Under 
no circumstances should the investigator or site personnel supply idelalisib to other investigators 
or clinics, or allow the idelalisib to be used other than as directed by this protocol.
The investigator and/or the responsible site personnel must maintain accurate records of the 
receipt of idelalisib shipped by Gilead Sciences or its designee, including, but not limited to, the 
date received, lot number, amount received, and the disposition of all idelalisib. Upon receipt of 
a drug shipment, the shipment must be logged into the idelalisib accountability records, these 
records must also be maintained to include the subject number to whom the idelalisib was 
dispensed and the date, quantity and lot number of the idelalisib dispensed.
Depending upon the decision of Gilead Sciences, remaining unused idelalisib supply will be 
returned to Gilead Sciences or its designee after the study is completed or will be discarded or 
destroyed at the clinical site. If the idelalisib is discarded or destroyed at the clinical site, 
standard institutional policy should be followed. Records documenting the date of idelalisib
shipping or destruction, relevant lot numbers, and amount shipped or destroyed should be 
maintained.
5.4.1.
Overdose Precautions
In Phase 1 studies, an MTD for idelalisib was not reached when administering the drug 
continuously at dose levels of 350 mg/dose BID (700 mg per day) {Coutre et al 2011}, {Kahl et 
al 2011}. However, in this protocol, an overdose is defined as administration of more than the 
prescribed daily dose (ie, >300 mg in a single day).
The Gilead Sciences medical monitor should be contacted if an idelalisib overdose occurs. Cases 
of idelalisib overdose will result in specific reporting requirements.
5.4.2.
Inadvertent Exposure and Spill Precautions
Based on available data from nonclinical studies, idelalisib does not appear to be acutely toxic, 
genotoxic, or irritative at levels that are likely to result from inadvertent exposure to the contents 
of broken tablets. However, personnel handling the drug should use reasonable precautions to 
avoid eye contact, skin contact, inhalation, or ingestion of the idelalisib product. For further 
information regarding inadvertent exposure and spill precautions, please consult the idelalisib
investigator brochure.

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5.4.3.
Investigational Medicinal Product Return or Disposal
Subjects will be instructed to return any unused idelalisib in the original container at post 
treatment study visits. Returned medication will be reconciled by the investigator in order to 
monitor the subject’s compliance with the medication regimen. When possible, all idelalisib
returned by the subject should be retained for review by the study site monitor prior to return to 
Gilead Sciences or destruction.
5.5.
Discontinuation from Study
Subject study participation may be ended due to any of the follow reasons:

Withdrawal of consent

Objective evidence of disease progression.

Unacceptable toxicity or unable to tolerate a second rechallenge for the same AE.

Any subject who becomes pregnant or begins breastfeeding.

Initiation of non-protocol specfied anticancer therapy.

Noncompliance with idelalisib administration, study procedures, or study requirements.

The investigator may discontinue idelalisib, if it is not in the subject’s best interest to 
continue.

Any subject who is lost to follow-up.

Death

Discontinuation of study by the Sponsor, a regulatory agency, or an EC

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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Table 6-1 and described in the text that follows. 
The investigator must document any deviation from protocol procedures and notify the sponsor 
or contract research organization (CRO).
6.1.
Subject Enrollment 
6.1.1.
Subject Recruitment
This study will enroll subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study 
closure who have had objective evidence of clinical benefit defined as at least stable disease on 
imaging assessed by the IRC and no toxicities prior to enrollment in this study that would
preclude initiating therapy with idelalisib. The study sponsor will post a description of the study 
on the ClinicalTrials.gov website.
6.1.2.
Subject Compensation for Participation
Subjects will not be paid for participation in the study other than medical care that may be 
provided. Payments for such items as lost wages, disability, discomfort due to injury, or meals 
obtained while waiting at the clinical research center will not be provided. Through the informed 
consent process, study candidates will be notified that their insurance company could be charged 
for standard care that is a component of this research study and that subjects may be responsible 
for co-payments and deductible payments that are typical for their insurance coverage.
6.1.3.
Screening Visit
The investigator must inform each prospective subject of the nature of the study, explain the 
potential risks, and obtain written informed consent from the subject and/or a legal guardian 
prior to performing any study-related screening procedures. 
From the time of obtaining informed consent through the first administration of investigational 
medicinal product, record all serious adverse events (SAEs), as well as any adverse events 
related to protocol-mandated procedures on the adverse events case report form (CRF/eCRF).  
All other untoward medical occurrences observed during the screening period, including 
exacerbation or changes in medical history are to be captured on the medical history CRF/eCRF.  
See Section 7 Adverse Events and Toxicity Management for additional details.
6.2.
Treatment Assessments
From the time of obtaining informed consent through the first administration of investigational 
medicinal product, record all SAEs, as well as any non-serious all grade AEs on the AE case 
report form (eCRF). All other untoward medical occurrences observed during the screening 

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period, including exacerbation or changes in pre-existing conditions are considered medical 
history (not collected for this study). See Adverse Events and Toxicity Management (Section 7) 
for additional details.
While on study, the subject will return at regular intervals for the following procedures:

Evaluation of disease status per standard of care

Laboratory lab tests (ALT/AST/total bilirubin)

Recording of all grade AEs and all SAEs

Return of used drug supplies and dispensing of new idelalisib supply
The specific study procedures to be conducted for each subject enrolled in the study are 
presented in Table 7-1 and are described in the sections that follow.
6.2.1.
Clinical Evaluation
While on study, the subject will be followed for disease status according to standard of care. At 
each study visit the subject’s disease status will be assessed. If no change in disease status is 
identified and the subject is dispensed additional idelalisib, the most recent prior response 
documented for the study will be recorded.
6.3.
End of Study
Subjects will be withdrawn from this study if they develop progressive disease, unacceptable 
toxicity related to idelalisib, withdraw consent, are noncompliant, or are lost to follow up or die. 
In this event, the following procedures should be performed:

Return of used and unused drug supply

Recording of all Grade AEs and all SAEs

Investigator Response Assessment

Recording of the reason for withdrawal

Deaths occurring within 30 days following the last dose of idelalisib, even if occurring after 
the End of Study Visit, will be captured.

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Table 6-1.
Schedule of Study Procedures
Period
Screen
Treatment
Visit
1
2
3
4
5
6
7
8+
End of
study
Week
-4
0
4
8
12
16
24
Q12 
weeks
Study Day
Within
-28 days
1
28
52
84
112
168
Visit Window
±2
±2
±2
±2
±2
±7
Informed consent
X
Serum -HCGa
X
ALT/AST/total bilirubin
X
X
X
X
X
X
X
X
X
Urine pregnancy testa
X
X
X
X
X
X
X
X
Assess adverse events and SAEs
X
X
X
X
X
X
X
X
Record concomitant medicationsb
X
X
X
X
X
X
X
X
Idelalisib dispensing/accounting
X
X
X
X
X
X
X
X
Investigator response assessmentc
X
X
X
X
X
X
X
X
a
For women of child bearing potential; Serum -HCG to be collected to be collected at screening, urine pregnancy test to be 
collected at visits from first dose of idelalisib to EOS
b
Concomitant medications only collected if it is related to an AE
c
Record investigator response assessment if obtained per standard of care
Abbreviations: -HCG=beta human chorionic gonadotropin, ALT=alanine aminotransferase, AST=aspartate aminotransferase

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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered a medicinal product, which does not necessarily have a causal relationship with the
treatment. An AE can therefore be any unfavorable and/or 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 specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or 
occupational exposure. Preexisting events that increase in severity or change in nature during or 
as a consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Lymphocytosis

Laboratory abnormalities not requiring clinical intervention or further investigation. Such 
abnormalities will be captured as part of overall laboratory monitoring.

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an adverse event and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
A serious adverse event (SAE) is defined as an event that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

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
In-patient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated medicinal 
product will be considered a medically important event and subject to expedited reporting 
requirements.
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that 
require medical or surgical intervention or lead to idelalisib interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, electrocardiogram, x-rays, vital signs) that are 
associated with signs and/or symptoms must be recorded as an AE or SAE if they meet the 
definition of an AE or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory 
abnormality is part of a syndrome, record the syndrome or diagnosis (eg, anemia), not the 
laboratory result (ie, decreased hemoglobin).
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified sub-investigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.
7.2.1.
Assessment of Causality for Idelalisib and Procedures
The investigator or qualified sub-investigator is responsible for assessing the relationship to 
idelalisib therapy using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than idelalisib. For 
SAEs, an alternative causality must be provided (eg, pre-existing condition, underlying 
disease, intercurrent illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.

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It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of adverse event reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the adverse event has an etiology other than the study procedure.

Yes: The adverse event occurred as a result of protocol procedures, (eg., venipuncture)
7.2.2.
Assessment of Severity
The severity of AEs will be graded using the CTCAE, Version 4.03 and available at:
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
If a CTCAE criterion does not exist, the investigator should use the grade or adjectives: 
Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or 
Grade 5 (fatal) to describe the maximum intensity of the adverse event. For purposes of 
consistency with the CTCAE, these intensity grades are defined in Table 7-1.
Table 7-1.
Grading of Adverse Event Severity
Grade
Adjective
Description
Grade 1
Mild
Sign or symptom is present, but it is easily tolerated, is not expected to have a 
clinically significant effect on the subject’s overall health and well-being, does 
not interfere with the subject’s usual function, and is not likely to require 
medical attention.
Grade 2
Moderate
Sign or symptom causes interference with usual activity or affect clinical status, 
and may require medical intervention.
Grade 3
Severe
Sign or symptom is incapacitating or significantly affects clinical status and 
likely requires medical intervention and/or close follow-up.
Grade 4
Life-threatening
Sign or symptom results in a potential threat to life.
Grade 5
Fatal
Sign or symptom results in death.
The distinction between the seriousness and the severity of an adverse event should be noted. 
Severe is a measure of intensity; thus, a severe reaction is not necessarily a serious reaction. For 
example, a headache may be severe in intensity, but would not be classified as serious unless it 
met one of the criteria for serious events listed in Section 7.1.2.
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead 
All SAEs, regardless of cause or relationship, that occur after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 

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eCRF database and Gilead Drug Safety and Public Health (DSPH) or designee as instructed. 
This also includes any SAEs resulting from protocol-associated procedures performed from 
screening onwards.
All AEs, regardless of cause or relationship, that occur from initiation of study medication until 
30 days after last administration of idelalisib must be reported to the eCRF database as 
instructed.
Any SAEs and deaths that occur after the post treatment follow-up visit but within 30 days of the 
last dose of idelalisib, regardless of causality, should also be reported.
All AEs should be followed up until resolution if possible. If by the last day on study (including 
the off-study medication follow-up period) the AE has not resolved, then the AE will be 
followed up until the investigator and/or Gilead Sciences determine that the subject's condition is 
stable. However, Gilead Sciences may request that certain AEs be followed until resolution.
Investigators are not obligated to actively seek SAEs after the 30 day period. However, if the 
investigator learns of any SAEs that occur after study participation has concluded and the event 
is deemed relevant to the use of idelalisib, he/she should promptly document and report the event 
to Gilead DSPH or designee as instructed.
All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guidelines.
7.3.1.
Serious Adverse Event (eSAE) Reporting Process 
Site personnel record the SAE on the paper serious adverse event reporting form and submit via 
fax to Gilead DSPH within 24 hours.
All AEs and SAEs will be recorded in the CRF/eCRF database within the timelines outlined in 
the CRF/eCRF completion guideline.
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.
Additional information may be requested to ensure the timely completion of accurate safety 
reports.
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF/eCRF and the event description section of the SAE 
form.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 

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worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or 
suspected unexpected serious adverse reactions (SUSARs). In accordance with the EU Clinical 
Trials Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant IEC in concerned Member States of applicable SUSARs as outlined in 
current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the investigator’s brochure or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with idelalisib. The investigator should notify the IEC of SUSAR reports as soon as is practical, 
where this is required by local regulatory agencies, and in accordance with the local institutional 
policy. 
7.4.1.
Reporting of Adverse Events Relating and Other Anticipated Medical Events 
in the Study Population
Given the endpoints of the study and in order to maintain the integrity of the study, the following 
events that are assessed as unrelated to idelalisib will not be considered SAEs:

Progression of lymphoid malignancy

Death related to progression of lymphoid malignancy

Disease progression and death from disease progression should be reported as SAEs by the 
investigator only if it is assessed that the idelalisib caused or contributed to the disease 
progression (ie, by a means other than lack of effect).  Unrelated disease progression should 
be captured on the eCRF.
These will be reported, as appropriate, in the final clinical study report and in any relevant 
aggregate safety reports.
7.4.2.
Toxicity Management 
See Table 5-2 for more information related to recommended dose modifications associated with 
toxicities. Please refer to the current idelalisib IB for information related to toxicity management.
7.5.
Special Situations Reports
7.5.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, reports 
of adverse events associated with product complaints, and pregnancy reports regardless of an 
associated AE.  
Medication error is any unintentional error in the prescribing, dispensing, or administration of a 
medicinal product while in the control of the health care provider, subject, or consumer.

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Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by a 
subject.
Misuse is defined as any intentional and inappropriate use of a medicinal product that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a medicinal 
product given per administration or cumulatively which is above the maximum recommended 
dose as per protocol or in the product labelling (as it applies to the daily dose of 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). Overdose cannot be established 
when the subject cannot account for the discrepancy except in cases in which the investigator has 
reason to suspect that the subject has taken the additional dose(s).
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the medicinal product.  
7.5.2.
Instructions for Reporting Special Situations
7.5.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study to the 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 AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Sections 7.1.1 and 7.1.2. Furthermore, any SAE occurring as an adverse pregnancy outcome post 
study must be reported to Gilead DSPH.
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. 
Pregnancies of female partners of male study subjects exposed to idelalisib must also be reported 
and relevant information should be submitted to Gilead DSPH using the pregnancy and 
pregnancy outcome forms within 24 hours. Monitoring of the subject should continue until the 
conclusion of the pregnancy. If the end of the pregnancy occurs after the study has been 
completed, the outcome should be reported directly to Gilead DSPH, fax number +1 650 522-5477
or email Safety_FC@gilead.com. 

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Refer to Appendix 2 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.
7.5.2.2.
Reporting Other Special Situations
All other special situation reports (excluding pregnancy) must be reported on the special 
situations report form and forwarded to Gilead DSPH within 24 hours of the investigator 
becoming aware of the situation. These reports must consist of situations that involve idelalisib, 
but do not apply to concomitant medications. Except for situations that result in AEs, special 
situations involving concomitant medication will not be reported. Any inappropriate use of 
concomitant medications prohibited by this protocol should not be reported as “misuse,” but may 
be more appropriately documented as a protocol deviation.
Refer to the CRF/eCRF completion guidelines for full instructions on the mechanism of special 
situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE CRF/eCRF and/or the SAE report form. Details of the symptoms 
and signs, clinical management, and outcome will be reported, when available.

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives
As noted in Section 2, the primary objective is to provide idelalisib to subjects receiving
GS-9820 in Study GS-US-315-0102 at the time of study closure who have had objective 
evidence of clinical benefit defined as at least stable disease on imaging assessed by the IRC and 
no toxicities prior to enrollment in this study that would preclude initiating therapy with 
idelalisib.
8.2.
Safety Endpoints
Safety will be assessed with endpoints including incidence of ≥Grade 3 AEs, SAEs, and deaths.
8.3.
Analysis Sets
Both safety and efficacy will be assessed using data collected from subjects who received at least 
1 dose of idelalisib.
8.4.
Analysis Methods
All the analyses will be limited to descriptive summaries and listings. Categorical variables will 
be summarized with the number and percentage of subjects in each category. Continuous 
variables will be summarized by presenting n, mean, standard deviation, median, Q1, Q3, 
minimum and maximum.
8.5.
Adverse Events
Clinical and laboratory adverse events will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA). System Organ Class (SOC), High-Level Group Term 
(HLGT), High-Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT) will be 
attached to the clinical database.

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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 accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and 
South Africa), International Conference on Harmonisation (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. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to 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.
The investigator and all applicable sub-investigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with Gilead, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any sub-investigator’s) participation in the study. The investigator and 
sub-investigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.2.
Independent Ethics Committee (IEC) Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, 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) to an IEC. The investigator will not begin any study subject activities until 
approval from the IEC has been documented and provided as a letter to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IEC any modifications made to the protocol or any accompanying material to be provided to 
the subject after initial IEC approval, with the exception of those necessary to reduce immediate 
risk to study subjects.
9.1.3.
Informed Consent
The investigator is responsible for obtaining 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 before undertaking any study-related procedures. The 
investigator must use the most current IEC-approved consent form for documenting written 
informed consent. Each informed consent (or assent as applicable) will be appropriately signed 

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and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IEC or local 
requirements. 
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, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form submitted to the Sponsor. NOTE: The investigator must keep a screening log showing 
codes, names, and addresses for all subjects screened and for all subjects enrolled in the trial.
Subject data will be processed in accordance with all applicable regulations. 
The investigator agrees that all information received from Gilead, including but not limited to the 
investigator brochure, this protocol, CRF/eCRF, idelalisib, and any other study information, 
remain the sole and exclusive property of Gilead 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 
Gilead. 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 at least the following two categories: (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.
The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);
Birth dates will be collected as per local regulatory requirements, as needed

Documentation that subject meets eligibility criteria, ie, history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);

Documentation of the reason(s) a consented subject is not enrolled

Participation in study (including study number);

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
Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of idelalisib, including dates of dispensing and 
return;

Record of all adverse events and other safety parameters (start and end date, and including 
causality and severity);

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. The 
investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. eCRF should be 
completed on the day of the subject visit to enable the sponsor to perform central monitoring of 
safety data. The Eligibility Criteria eCRF should be completed only after all data related to 
eligibility have been received.  Subsequent to data entry, a study monitor will perform source 
data verification within the EDC system. Original entries as well as any changes to data fields 
will be stored in the audit trail of the system.  Prior to database lock (or any interim time points 
as described in the clinical data management plan), the investigator will use his/her log in 
credentials to confirm that the forms have been reviewed, and that the entries accurately reflect 
the information in the source documents. The eCRF capture the data required per the protocol 

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schedule of events and procedures. System-generated or manual queries will be issued to the 
investigative site staff as data discrepancies are identified by the monitor or internal Gilead staff, 
who routinely review the data for completeness, correctness, and consistency. The site 
coordinator is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (eg data entry error). At the conclusion of the trial, Gilead will provide the site 
with a read-only archive copy of the data entered by that site. This archive must be stored in 
accordance with the records retention requirements outlined in Section 9.1.5.
9.1.7.
Drug Accountability and Return
Gilead recommends that used and unused idelalisib supplies be returned to the shipping facility 
from which it came for eventual destruction. The study monitor will provide instructions for 
return. If return is not possible, the study monitor will evaluate each study center’s disposal 
procedures and provide appropriate instruction for destruction of unused idelalisib supplies. If 
the site has an appropriate standard operating procedure (SOP) for drug destruction as 
determined by Gilead QA, the site may destroy used (empty or partially empty) and unused 
idelalisib supplies in accordance with that site’s approved SOP. A copy of the site’s approved 
SOP will be obtained for central files. 
If idelalisib is destroyed on site, the investigator must maintain accurate records for all idelalisib
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the idelalisib. Upon study completion, copies of 
the idelalisib accountability records must be filed at the site. Another copy will be returned to 
Gilead.
The study monitor will review idelalisib supplies and associated records at periodic intervals.
9.1.8.
Inspections
The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, to appropriately qualified personnel from Gilead Sciences 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.
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 Gilead. The investigator must submit all protocol modifications to the IEC in 
accordance with local requirements and receive documented IEC approval before modifications 
can be implemented.

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9.2.2.
Communications with Regulatory Authorities
Gilead Sciences, working either directly or through designees, will assume responsibility for 
regulatory interactions with relevant regulatory authorities. Gilead Sciences will maintain an 
IND for idelalisib in support of the study in the United States and will maintain similar 
regulatory applications with other regulatory authorities, as required for conduct of the study. In 
fulfilling this responsibility, Gilead Sciences (or a designee) will collect, assemble, and 
communicate all required regulatory documents (eg, Form FDA 1572, investigator financial 
disclosure forms, protocol and protocol amendments, investigator brochures, informed consent 
documents, annual reports) as required by regulation. Gilead Sciences (or a designee) will also 
assume responsibility for adverse event reporting to regulatory authorities as described in 
Section 7.4.
9.2.3.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies). Gilead 
will ensure that the report meets the standards set out in the ICH Guideline for Structure and 
Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in 
certain cases.
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 
Gilead in an abstract, manuscript, or presentation form or the study has been completed at all 
study sites for at least 2 years.
The investigator will submit to Gilead any proposed publication or presentation along with the 
respective scientific journal or presentation forum at least 30 days before submission of the 
publication or presentation. 
No such communication, presentation, or publication will include Gilead’s confidential 
information (see Section 9.1.4).
The investigator will comply with Gilead’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.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol, eg attendance at Investigator's Meetings.  If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value.

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9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
CRF/eCRF.
The monitor is responsible for routine review of the CRF/eCRF 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 CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead 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 Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
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 authority(ies) and IECs. In terminating the study, Gilead and the investigator will 
assure that adequate consideration is given to the protection of the subjects’ interests.

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10.
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Outcomes for patients who fail high dose chemoradiotherapy and autologous stem 
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements

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Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
199 EAST BLAJNE STREET 
SEATTLE, WA 98102 
STUDY ACKNOWLEDGEMENT 
An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated with 
the Investigational PI3Ko Inhibitor, GS-9820 
Original Protocol GS-US-313-2120, 05 January 2016 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
po-------------------. 
Lyndah Dreiling, MD 
Gilead Medical Monitor 
Date 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains aJI 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. 
I wiU provide aJl study personnel under my supervision copies of the protocol and access to aU 
information provided by Gilead Sciences, Inc. 1 will discuss this material with them to ensure 
that tbey are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTW. 
Page 45 
05 January 2016 

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Appendix 2.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a) Definition of Childbearing Potential
For the purposes of this study, a female born subject is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming post-menopausal, unless 
permanently sterile or with medically documented ovarian failure.  
Women are considered to be in a postmenopausal state when they are > 54 years of age with 
cessation of previously occurring menses for > 12 months without an alternative cause.  In 
addition, women of any age with amenorrhea of > 12 months may also be considered 
postmenopausal if their follicle stimulating hormone (FSH) level is in the postmenopausal range 
and they are not using hormonal contraception or hormonal replacement therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female subject of any age.
b) Definition of Male Fertility
For the purposes of this study, a male born subject is considered fertile after the initiation of 
puberty unless permanently sterile by bilateral orchidectomy or medical documentation.
2) Contraception Requirements for Female Subjects
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Idelalisib has insufficient data to exclude the possibility of a clinically relevant interaction with 
hormonal contraception that results in reduced contraception efficacy.  Therefore, contraceptive 
steroids are not recommended as a contraceptive method either solely or as a part of a 
contraceptive regimen.  Data from clinical pharmacokinetic interaction studies of idelalisib have 
demonstrated no adverse effect on fertility or embryo-fetal development.  However, there is no 
clinical data of idelalisib in pregnant women.  Please refer to the latest version of the 
investigator’s brochure for additional information. 
b) Contraception Requirements for Female Subjects of Childbearing Potential
The inclusion of female subjects of childbearing potential requires using at least an acceptable 
effective contraceptive measure.  They must also not rely on hormone-containing contraceptives 
as a form of birth control during the study.  They must have a negative serum pregnancy test at 
Screening and a negative pregnancy test on the Baseline/Day 1 visit prior to randomization.  At 
minimum, a pregnancy test will be performed at the end of relevant systemic exposure.  In the 

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event of a delayed menstrual period (over one month between menstruations), a pregnancy test 
must be performed to rule out pregnancy.  This is even true for women of childbearing potential 
with infrequent or irregular periods.  They must also agree to one of the following from 
Screening until 30 days after the end of relevant systemic exposure.
Complete abstinence from intercourse of reproductive potential.  Abstinence is an acceptable 
method of contraception only when it is in line with the subject’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below. 

Intrauterine device (IUD) with a failure rate of <1% per year

Tubal sterilization

Ensure micro-insert system (provided confirmation of success 3 months after procedure)

Vasectomy in the male partner (provided that the partner is the sole sexual partner and had 
confirmation of surgical success 3 months after procedure)

Barrier methods (one female barrier and one male barrier must be used in combination)
Female barriers: Diaphragm with spermicide or Cervical cap with spermicide
Male barriers: Male condom (with or without spermicide)
Female subjects must also refrain from egg donation and in vitro fertilization during treatment 
and until at least 30 days after the end of relevant systemic exposure
3) Contraception Requirements for Male Subjects
Male subjects must also refrain from sperm donation during treatment and until at least 90 days 
after the end of relevant systemic exposure.
It is theoretically possible that a relevant systemic concentration may be achieved in a female 
partner from exposure of the male subject’s seminal fluid.  Therefore, male subjects with female 
partners of childbearing potential must use condoms during treatment until the end of relevant 
systemic exposure.
4) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method (LAM).  Female condom and male condom should not be used 
together.

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5) Procedures to be Followed in the Event of Pregnancy
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days of last idelalisib dose. Subjects who become 
pregnant or who suspect that they are pregnant during the study must report the information to 
the investigator and discontinue idelalisib immediately. Subjects whose partner has become 
pregnant or suspects she is pregnant during the study must report the information to the 
investigator.  Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome 
are outlined in Section 7.5.2.1.