Trial Outcomes & Findings for Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512) (NCT NCT01539291)

Last Updated: 2019-08-20

Results Overview

PFS was defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria other than lymphocytosis alone. PFS was analyzed using Kaplan-Meier (KM) estimates.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

161 participants

Primary outcome timeframe

GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Results posted on

2019-08-20

Participant Flow

Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 03 October 2012. The last study visit occurred on 29 June 2018.

Participants must have been enrolled in Gilead-sponsored Study GS-US-312-0116 (NCT01539512) to be eligible to continued access to idelalisib (IDL) in this study.

Participant milestones

Participant milestones
Measure	IDL+R to IDL 150 mg Participants received IDL 150 mg tablet twice daily plus rituximab (R) (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	IDL+R (PD) to IDL 300 mg Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of progressive disease (PD) and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily. Due to the small number of participants in this group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Study GS-US-312-0116 STARTED	106	4	42	44
Study GS-US-312-0116 COMPLETED	81	4	42	44
Study GS-US-312-0116 NOT COMPLETED	25	0	0	0
Study GS-US-312-0117 STARTED	71	4	42	44
Study GS-US-312-0117 COMPLETED	30	2	20	18
Study GS-US-312-0117 NOT COMPLETED	41	2	22	26

Reasons for withdrawal

Reasons for withdrawal
Measure	IDL+R to IDL 150 mg Participants received IDL 150 mg tablet twice daily plus rituximab (R) (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	IDL+R (PD) to IDL 300 mg Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of progressive disease (PD) and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily. Due to the small number of participants in this group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Study GS-US-312-0116 Adverse Event	9	0	0	0
Study GS-US-312-0116 Physician Decision	1	0	0	0
Study GS-US-312-0116 Withdrawal by Subject	12	0	0	0
Study GS-US-312-0116 Study Terminated by Sponsor	2	0	0	0
Study GS-US-312-0116 Other	1	0	0	0
Study GS-US-312-0117 Adverse Event	22	1	9	12
Study GS-US-312-0117 Physician Decision	9	0	6	4
Study GS-US-312-0117 Withdrawal by Subject	5	0	6	4
Study GS-US-312-0117 Study Terminated by Sponsor	3	0	0	5
Study GS-US-312-0117 Other	2	1	1	1

Baseline Characteristics

Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Total n=196 Participants Total of all reporting groups
Age, Customized < 65 years	21 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	44 Participants n=4 Participants
Age, Customized ≥ 65 years	89 Participants n=5 Participants	29 Participants n=7 Participants	34 Participants n=5 Participants	152 Participants n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants	63 Participants n=4 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	31 Participants n=7 Participants	26 Participants n=5 Participants	133 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	101 Participants n=5 Participants	39 Participants n=7 Participants	42 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	6 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	100 Participants n=5 Participants	37 Participants n=7 Participants	40 Participants n=5 Participants	177 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Permitted	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment United States	80 Participants n=5 Participants	38 Participants n=7 Participants	30 Participants n=5 Participants	148 Participants n=4 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Italy	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment France	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Germany	7 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
17p Deletion and/or TP53 Mutation Status Either	46 Participants n=5 Participants	21 Participants n=7 Participants	14 Participants n=5 Participants	81 Participants n=4 Participants
17p Deletion and/or TP53 Mutation Status Neither	64 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants	115 Participants n=4 Participants
Immunoglobulin heavy chain variable region (IgHV) Mutation Status Mutated	19 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Immunoglobulin heavy chain variable region (IgHV) Mutation Status Unmutated	91 Participants n=5 Participants	36 Participants n=7 Participants	37 Participants n=5 Participants	164 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 40	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 50	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 60	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 70	20 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	28 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 80	42 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	81 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 90	23 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	47 Participants n=4 Participants
Karnofsky Performance Status (KPS) KPS = 100	15 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants

PRIMARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Full Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set (all participants randomized in Study GS-US-312-0116) who received ≥ 1 dose of IDL, with treatment assignments designated according to randomization in Study GS-US-312-0116.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Progression-Free Survival (PFS)	20.3 months Interval 17.3 to 26.3	6.9 months Interval 4.1 to 10.7	16.2 months Interval 8.8 to 26.2	—

PRIMARY outcome

Timeframe: First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months) plus 4 weeks

Population: Participants in the Full Analysis Set were analyzed.

The TEAEs were defined as events in a given study period that met one of the following criteria: * Events with onset dates on or after the start of treatment and up to 30 days after the permanent discontinuation of the study treatment. * The continuing adverse events (AEs) diagnosed prior to the start of treatment and worsened in severity grade, or non-serious AEs at baseline which became serious, or AEs resulting in treatment discontinuation after the start of treatment. The severity of AEs was graded by the investigator according to the common terminology criteria for adverse events (CTCAE), Version 4.03, whenever possible. The relationship of an AE to study drug (idelalisib) was assessed using clinical judgment by the investigator, describing the event as either unrelated or related. Events for which the investigator did not record relationship to study drug were considered related to study drug.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation Any TEAE	98.2 percentage of participants	100.0 percentage of participants	97.7 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation ≥ Grade 3 TEAE	90.9 percentage of participants	88.1 percentage of participants	90.9 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation Study Drug-Related TEAE	68.2 percentage of participants	59.5 percentage of participants	72.7 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation ≥ Grade 3 Study Drug-Related TEAE	47.3 percentage of participants	45.2 percentage of participants	45.5 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation Serious TEAE	80.9 percentage of participants	81.0 percentage of participants	72.7 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation Study Drug-Related Serious TEAE	35.5 percentage of participants	26.2 percentage of participants	29.5 percentage of participants	—
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation TEAE Leading to Study Drug Discontinuation	47.3 percentage of participants	64.3 percentage of participants	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set were analyzed.

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR). The determination of CLL response and progression were based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, as specifically modified for this study to reflect current recommendations which considered the mechanism of action of idelalisib and similar drugs. CR and PR are defined in Protocol Amendment 9, Sections 7.5.1 and 7.5.2.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Overall Response Rate (ORR)	85.5 percentage of participants Interval 77.5 to 91.5	47.6 percentage of participants Interval 32.0 to 63.6	68.2 percentage of participants Interval 52.4 to 81.4	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set with available data were analyzed.

Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=106 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=36 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=43 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Lymph Node Response Rate	97.2 percentage of participants Interval 92.0 to 99.4	77.8 percentage of participants Interval 60.8 to 89.9	83.7 percentage of participants Interval 69.3 to 93.2	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set were analyzed.

CR rate was defined as the percentage of participants who achieved a CR (full definition in Protocol Amendment 9, Section 7.5.1). The determination of CLL response and progression were based on standardized IWCLL criteria, as specifically modified for this study to reflect current recommendations which considered the mechanism of action of idelalisib and similar drugs.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Complete Response (CR) Rate	0.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who achieved a CR or PR were analyzed.

TTR was defined as the time interval from start of study therapy to the first documentation of CR or PR.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=94 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=20 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=30 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Time to Response (TTR)	2.1 months Interval 1.9 to 3.8	3.6 months Interval 1.9 to 4.0	2.8 months Interval 1.9 to 4.2	—

SECONDARY outcome

Timeframe: From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who achieved a CR or PR were analyzed.

DOR was defined as the time interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. DOR was analyzed using KM estimates.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=94 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=20 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=30 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Duration of Response (DOR)	21.4 months Interval 16.6 to 26.1	11.0 months Interval 3.3 to NA = Too few events to estimate the upper limit of the confidence interval.	17.6 months Interval 13.2 to 37.7	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set with available data were analyzed.

The best percent change from baseline in lymph node area (SPD) was defined as the largest decrease in tumor size during the study. The baseline SPD was the last value prior to the baseline reference date. For the participants who only had increases in tumor size from baseline, the smallest increase was considered as the best change from baseline in SPD.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=106 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=36 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=43 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Best Percent Change in Lymph Node Area	-80.1 percent change Interval -86.1 to -70.5	-69.7 percent change Interval -79.5 to -53.7	-71.4 percent change Interval -80.4 to -62.7	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had splenomegaly at baseline and at least 1 evaluable postbaseline spleen measurement were analyzed.

Splenomegaly response rate was defined as the percentage of participants with baseline splenomegaly who achieved an on-study normalization or a 50% decrease (minimum 2 cm) from baseline in the enlargement of the splenic longest vertical dimension (LVD) (by imaging).

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=76 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=23 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=24 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Splenomegaly Response Rate	80.3 percentage of participants Interval 69.5 to 88.5	47.8 percentage of participants Interval 26.8 to 69.4	66.7 percentage of participants Interval 44.7 to 84.4	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had hepatomegaly at baseline and at least 1 evaluable postbaseline liver measurement were analyzed.

Hepatomegaly response rate was defined as the percentage of participants with baseline hepatomegaly who achieved an on-study normalization or a 50% decrease (minimum 2 cm) from baseline in the hepatic LVD (by imaging).

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=54 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=22 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=20 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Hepatomegaly Response Rate	63.0 percentage of participants Interval 48.7 to 75.7	36.4 percentage of participants Interval 17.2 to 59.3	30.0 percentage of participants Interval 11.9 to 54.3	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had lymphocytosis (ALC ≥ 4 × 10\^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.

ALC response rate was defined as the percentage of participants with baseline lymphocytosis (ALC ≥ 4 x 10\^9 cells/L) who achieved an on-study ALC \< 4 x 10\^9 cells/L or demonstrated a ≥ 50% decrease in ALC from baseline; ALC values within 4 weeks post-baseline were excluded from the ALC response rate evaluation.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=88 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=27 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=34 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Absolute Lymphocyte Count (ALC) Response Rate	94.3 percentage of participants Interval 87.2 to 98.1	66.7 percentage of participants Interval 46.0 to 83.5	64.7 percentage of participants Interval 46.5 to 80.3	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had thrombocytopenia (platelet count \< 100 × 10\^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.

Platelet response rate was defined as the percentage of participants with baseline thrombocytopenia (platelet count \< 100 x 10\^9/L) who achieved an on-study platelet count ≥ 100 x 10\^9/L or demonstrated a ≥ 50% increase in platelet count from baseline; platelet values within 4 weeks post-baseline or after 8 days post transfusion were excluded from the platelet response rate evaluation.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=50 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=23 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=10 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Platelet Response Rate	98.0 percentage of participants Interval 89.4 to 99.9	73.9 percentage of participants Interval 51.6 to 89.8	100.0 percentage of participants Interval 69.2 to 100.0	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had anemia (hemoglobin \< 110 g/L \[11 g/dL\]) at baseline and at least 1 evaluable postbaseline value were analyzed.

Hemoglobin response rate was defined as the percentage of participants with baseline anemia (hemoglobin \< 110 g/L \[11.0 g/dL\]) who achieved an on-study hemoglobin ≥ 110 g/L (11.0 g/dL) or demonstrated a ≥ 50% increase in hemoglobin from baseline; hemoglobin values within 4 weeks post-baseline or after 4 weeks of receiving packed cell/whole blood transfusion or after 6 weeks of receiving exogenous growth factors (eg, darbepoetin alfa) were excluded from the hemoglobin response evaluation.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=59 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=24 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=11 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Hemoglobin Response Rate	83.1 percentage of participants Interval 71.0 to 91.6	45.8 percentage of participants Interval 25.6 to 67.2	81.8 percentage of participants Interval 48.2 to 97.7	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Participants in the Full Analysis Set who had neutropenia (ANC ≤ 1.5 × 10\^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.

Neutrophil response rate was defined as the percentage of participants with baseline neutropenia (absolute neutrophil count \[ANC\] ≤ 1.5 x 10\^9/L) who achieved an ANC \> 1.5 x 10\^9/L or demonstrated a ≥ 50% increase in ANC from baseline; ANC values within 4 weeks of post-baseline or after 2 weeks of receiving exogenous growth factors (eg, filgrastim, granulocyte-colony stimulating factor \[G-CSF\], lenograstim) or after 4 weeks of receiving Neulasta® were excluded from response evaluation.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=27 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=11 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=6 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Neutrophil Response Rate	96.3 percentage of participants Interval 81.0 to 99.9	90.9 percentage of participants Interval 58.7 to 99.8	100.0 percentage of participants Interval 54.1 to 100.0	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Per the analysis plan, overall survival data was analyzed in the ITT Analysis Set (participants who were randomized in the study) by treatment group according to the original randomization in Study GS-US-312-0116, regardless of whether participants received any study drug, or received a different regimen from the regimen they were randomized to.

Overall survival was defined as the time interval from start of study therapy to death from any cause. Overall survival was analyzed using KM estimates. Data presented includes all available survival information from Study GS-US-312-0116 (including data in long-term follow-up) and Study GS-US-312-0117 (including any data in long-term follow-up) up to the database finalization dates. Data from surviving participants were censored at the last time that the participant was known to be alive on study or long-term follow-up. Data presented includes all participants who were randomized to Study GS-US-312-0116 regardless if they entered Study GS-US-312-0117 or not.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=110 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Overall Survival	40.6 months Interval 28.5 to 57.3	34.6 months Interval 16.0 to NA = Too few events to estimate the upper limit of the confidence interval.	—	—

SECONDARY outcome

Timeframe: Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 184

Population: Participants in the Full Analysis Set with available data were analyzed.

The FACT-Leu questionnaire included subscales for physical well-being (PWB, 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB, 6 items), functional well-being (FWB, 7 items), and additional concerns or Leukemia-Specific Subscale (LeuS, 17 items). The FACT-Leu scoring guide identified those negatively stated items that must have been reversed before being added to obtain subscale totals. Negatively stated items were reversed by subtracting the response from "4". After reversing proper items, all subscale items were summed to get total subscale scores with the range of 0-28, 0-28, 0-24, 0-28, 0-68 for PWB, SWB, EWB, FWB, and LeuS, respectively. FACT-Leu total score ranged from 0 to 176. Higher scores indicated a better quality of life. Best change from baseline was defined as the highest value of change from baseline among all postbaseline visits. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=107 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire Total Score: Baseline	128.4 units on a scale Standard Deviation 22.72	116.7 units on a scale Standard Deviation 29.56	128.1 units on a scale Standard Deviation 29.16	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire PWB: Baseline	22.8 units on a scale Standard Deviation 4.42	20.2 units on a scale Standard Deviation 5.93	21.9 units on a scale Standard Deviation 5.41	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire SWB: Baseline	22.5 units on a scale Standard Deviation 5.53	22.5 units on a scale Standard Deviation 5.06	23.5 units on a scale Standard Deviation 5.04	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire EWB: Baseline	19.1 units on a scale Standard Deviation 3.44	17.3 units on a scale Standard Deviation 4.97	17.6 units on a scale Standard Deviation 4.48	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire FWB: Baseline	18.0 units on a scale Standard Deviation 6.57	15.0 units on a scale Standard Deviation 7.17	18.0 units on a scale Standard Deviation 6.88	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire LeuS: Baseline	46.0 units on a scale Standard Deviation 10.64	41.7 units on a scale Standard Deviation 12.74	47.0 units on a scale Standard Deviation 12.01	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire Total Score: Best Change from Baseline	21.8 units on a scale Standard Deviation 19.64	20.2 units on a scale Standard Deviation 19.91	14.9 units on a scale Standard Deviation 12.04	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire PWB: Best Change from Baseline	3.1 units on a scale Standard Deviation 4.65	3.6 units on a scale Standard Deviation 4.26	3.4 units on a scale Standard Deviation 3.81	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire SWB: Best Change from Baseline	2.9 units on a scale Standard Deviation 5.21	2.0 units on a scale Standard Deviation 2.88	2.1 units on a scale Standard Deviation 2.39	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire EWB: Best Change from Baseline	3.1 units on a scale Standard Deviation 2.75	3.1 units on a scale Standard Deviation 3.68	2.8 units on a scale Standard Deviation 3.14	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire FWB: Best Change from Baseline	5.1 units on a scale Standard Deviation 5.80	4.1 units on a scale Standard Deviation 5.01	3.1 units on a scale Standard Deviation 2.94	—
Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire LeuS: Best Change from Baseline	11.3 units on a scale Standard Deviation 9.13	10.1 units on a scale Standard Deviation 8.78	7.8 units on a scale Standard Deviation 5.59	—

SECONDARY outcome

Timeframe: Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 190

Population: Participants in the Full Analysis Set with available data were analyzed.

KPS is a tool used to measure the ability to perform ordinary tasks. The score ranges from 0 to 100, with a higher score indicating that the participant is better able to carry out daily activities. Best change from baseline was defined as the highest value of change from baseline among all postbaseline visits. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Best Change From Baseline in Karnofsky Performance Status (KPS) Baseline	80.7 units on a scale Standard Deviation 12.47	78.1 units on a scale Standard Deviation 14.18	86.8 units on a scale Standard Deviation 8.83	—
Best Change From Baseline in Karnofsky Performance Status (KPS) Best Change From Baseline	11.1 units on a scale Standard Deviation 10.31	7.1 units on a scale Standard Deviation 8.67	4.3 units on a scale Standard Deviation 6.98	—

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: Data were not collected because there was insufficient volume of sample (not enough material) to perform the analysis for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)

Population: The cytokine and T-cell subsets biomarker analysis set included all participants who received at least one dose of study drug, consented for optional future study, and had at least one evaluable measurement for any biomarker at any visit on IDL treatment. Available samples were batched for analysis as prespecified.

The percent of average on-treatment biomarker concentration of baseline (%Baseline) was used to evaluate the overall pharmacodynamics change on the biomarkers with IDL treatment. The average on-treatment biomarker concentration is calculated using area under curve (AUC) following the trapezoidal rule. The biomarkers with median AUC value of 100 indicated no overall on-treatment biomarker changes compared to the baseline. The biomarkers with median AUC value greater than 100 or less than 100 indicated an increase or decrease, respectively, on-treatment biomarker changes from the baseline.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=174 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines Tumor Necrosis Factor (TNF)-alpha	36.73 percentage of baseline Interval 5.34 to 183.56	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines Macrophage Inflammatory Protein (MIP)1-alpha	26.55 percentage of baseline Interval 3.76 to 236.22	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines Interleukin (IL)-10	58.65 percentage of baseline Interval 2.36 to 1706.34	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-15	111.18 percentage of baseline Interval 51.28 to 230.1	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-12p40	64.89 percentage of baseline Interval 11.3 to 2012.31	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines RANTES (CCL5)	131.94 percentage of baseline Interval 6.76 to 3715.99	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-1ra	114.22 percentage of baseline Interval 11.64 to 608.17	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines Interferon (IFN)-gamma	127.72 percentage of baseline Interval 10.55 to 4736.96	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines C-Reactive Protein (CRP)	132.38 percentage of baseline Interval 9.67 to 7625.53	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IFN-gamma-induced protein (IP)-10 (CXCL10)	88.5 percentage of baseline Interval 15.24 to 786.21	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-7	91.82 percentage of baseline Interval 14.47 to 960.7	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines Granulocyte-colony stimulating factor (G-CSF)	96.59 percentage of baseline Interval 3.83 to 1586.48	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-17A	100 percentage of baseline Interval 8.8 to 1311.69	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-6	100 percentage of baseline Interval 7.13 to 2817.44	—	—	—
Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines IL-8	102.59 percentage of baseline Interval 2.47 to 1724.25	—	—	—

SECONDARY outcome

Timeframe: First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months)

Population: Participants in the Full Analysis Set were analyzed.

Adherence percentage was calculated as the sum of tablets dispensed - the sum of tablets returned divided by the sum of the overall dosing period (total daily tablets x dosing duration), taking into account investigator-prescribed interruptions.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=110 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment Adherence ≥ 75%	100.0 percentage of participants	97.6 percentage of participants	100.0 percentage of participants	—
Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment Adherence < 75%	0.0 percentage of participants	2.4 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

Population: Participants in the pharmacokinetic (PK) Analysis Set (participants in the Full Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest) with available data were analyzed.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=40 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=3 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=30 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=29 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 4: Predose	384.0 ng/mL Interval 166.5 to 681.5	470.0 ng/mL Interval 317.0 to 631.0	301.5 ng/mL Interval 195.0 to 494.0	412.0 ng/mL Interval 211.0 to 646.0
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 4: 1.5 Hours Postdose	2115.0 ng/mL Interval 1370.0 to 2750.0	3940.0 ng/mL Interval 1550.0 to 4000.0	2580.0 ng/mL Interval 1880.0 to 3080.0	1720.0 ng/mL Interval 1200.0 to 2660.0
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 12: Predose	370.0 ng/mL Interval 196.0 to 745.0	570.0 ng/mL Interval 355.0 to 643.0	335.0 ng/mL Interval 190.0 to 470.0	298.0 ng/mL Interval 212.0 to 691.0
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 12: 1.5 Hours Postdose	2110.0 ng/mL Interval 1595.0 to 2665.0	3800.0 ng/mL Interval 3160.0 to 4710.0	2245.0 ng/mL Interval 1655.0 to 3255.0	1940.0 ng/mL Interval 1430.0 to 2450.0
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 24: Predose	307.0 ng/mL Interval 179.0 to 584.0	637.0 ng/mL Interval 524.0 to 930.0	362.0 ng/mL Interval 162.0 to 550.0	350.5 ng/mL Interval 261.0 to 504.5
Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib Week 24: 1.5 Hours Postdose	2270.0 ng/mL Interval 1560.0 to 2790.0	5630.0 ng/mL Interval 5550.0 to 5660.0	2180.0 ng/mL Interval 1760.0 to 2980.0	2010.0 ng/mL Interval 1210.0 to 2430.0

SECONDARY outcome

Timeframe: Study GS-US-312-0116 or GS-US-312-0117 Baseline; Weeks 24 and 48

Population: Participants in the Full Analysis Set with available data were analyzed.

Change in health status was defined as the change from baseline in overall health and single-item dimension scores as assessed using the EQ-5D utility measure. Percentage of participants with different level of problem were reported. Level 1: indicated no problem; Level 2: indicated some problems; and Level 3: indicated extreme problems. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116.

Outcome measures

Outcome measures
Measure	IDL+R to IDL n=108 Participants Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.	Placebo+R (PD) to IDL 150 mg n=42 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg n=44 Participants Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.	Placebo+R to IDL 150 mg Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Anxiety/Depression, Level 1	70.4 percentage of participants	50.0 percentage of participants	56.8 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Anxiety/Depression, Level 2	28.7 percentage of participants	42.9 percentage of participants	43.2 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Anxiety/Depression, Level 3	0.9 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Mobility, Level 1	60.2 percentage of participants	38.1 percentage of participants	61.4 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Mobility, Level 2	39.8 percentage of participants	59.5 percentage of participants	38.6 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Mobility, Level 3	0.0 percentage of participants	2.4 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Pain/Discomfort, Level 1	53.3 percentage of participants	50.0 percentage of participants	45.5 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Pain/Discomfort, Level 2	39.3 percentage of participants	45.2 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Pain/Discomfort, Level 3	7.5 percentage of participants	4.8 percentage of participants	4.5 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Self-Care, Level 1	90.7 percentage of participants	76.2 percentage of participants	84.1 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Self-Care, Level 2	9.3 percentage of participants	19.0 percentage of participants	15.9 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Self-Care, Level 3	0.0 percentage of participants	4.8 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Usual Activities, Level 1	56.5 percentage of participants	28.6 percentage of participants	52.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Usual Activities, Level 2	36.1 percentage of participants	52.4 percentage of participants	45.5 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Baseline: Usual Activities, Level 3	7.4 percentage of participants	19.0 percentage of participants	2.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Anxiety/Depression, Level 1	83.1 percentage of participants	65.0 percentage of participants	69.6 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Anxiety/Depression, Level 2	15.6 percentage of participants	35.0 percentage of participants	30.4 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Anxiety/Depression, Level 3	1.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Mobility, Level 1	70.1 percentage of participants	65.0 percentage of participants	69.6 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Mobility, Level 2	29.9 percentage of participants	35.0 percentage of participants	30.4 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Mobility, Level 3	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Pain/Discomfort, Level 1	62.3 percentage of participants	65.0 percentage of participants	43.5 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Pain/Discomfort, Level 2	35.1 percentage of participants	30.0 percentage of participants	47.8 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Pain/Discomfort, Level 3	2.6 percentage of participants	5.0 percentage of participants	8.7 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Self-Care, Level 1	92.2 percentage of participants	85.0 percentage of participants	91.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Self-Care, Level 2	6.5 percentage of participants	15.0 percentage of participants	8.7 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Self-Care, Level 3	1.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Usual Activities, Level 1	68.4 percentage of participants	75.0 percentage of participants	60.9 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Usual Activities, Level 2	28.9 percentage of participants	25.0 percentage of participants	34.8 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 24: Usual Activities, Level 3	2.6 percentage of participants	0.0 percentage of participants	4.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Anxiety/Depression, Level 1	84.1 percentage of participants	90.0 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Anxiety/Depression, Level 2	15.9 percentage of participants	10.0 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Anxiety/Depression, Level 3	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Mobility, Level 1	72.7 percentage of participants	60.0 percentage of participants	66.7 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Mobility, Level 2	27.3 percentage of participants	40.0 percentage of participants	33.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Mobility, Level 3	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Pain/Discomfort, Level 1	56.8 percentage of participants	60.0 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Pain/Discomfort, Level 2	43.2 percentage of participants	30.0 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Pain/Discomfort, Level 3	0.0 percentage of participants	10.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Self-Care, Level 1	95.5 percentage of participants	90.0 percentage of participants	83.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Self-Care, Level 2	4.5 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Self-Care, Level 3	0.0 percentage of participants	10.0 percentage of participants	0.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Usual Activities, Level 1	72.7 percentage of participants	70.0 percentage of participants	50.0 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Usual Activities, Level 2	25.0 percentage of participants	20.0 percentage of participants	33.3 percentage of participants	—
Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure Week 48: Usual Activities, Level 3	2.3 percentage of participants	10.0 percentage of participants	16.7 percentage of participants	—

Adverse Events

IDL+R to IDL 150 mg

Serious events: 54 serious events

Other events: 70 other events

Deaths: 37 deaths

IDL+R (PD) to IDL 300 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Placebo+R (PD) to IDL 150 mg

Serious events: 34 serious events

Other events: 41 other events

Deaths: 25 deaths

Placebo+R to IDL 150 mg

Serious events: 32 serious events

Other events: 43 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other 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
Publication restrictions are in place

Restriction type: OTHER