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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006293-72 | EudraCT Number |
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The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose Idelalisib | Experimental | Participants will receive idelalisib 300 mg twice daily (600 mg per day). |
|
| Standard-dose Idelalisib | Experimental | Participants will receive idelalisib 150 mg twice daily (300 mg per day) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Idelalisib tablet(s) administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| 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 | The TEAEs were defined as events in a given study period that met one of the following criteria:
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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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. |
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Key Inclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Arizona Oncology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330 | ||
| Result | Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011) | ||
| 30995176 | Result | Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | IDL+R (PD) to IDL 300 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study GS-US-312-0116 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Jan 23, 2012 | Apr 3, 2019 |
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| GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Lymph Node Response Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Complete Response (CR) Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Time to Response (TTR) | TTR was defined as the time interval from start of study therapy to the first documentation of CR or PR. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Duration of Response (DOR) | 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. | From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Best Percent Change in Lymph Node Area | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Splenomegaly Response Rate | 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). | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Hepatomegaly Response Rate | 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). | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Absolute Lymphocyte Count (ALC) Response Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Platelet Response Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Hemoglobin Response Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Neutrophil Response Rate | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Overall Survival | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| 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 | 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. | Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 184 |
| Best Change From Baseline in Karnofsky Performance Status (KPS) | 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. | Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 190 |
| Changes From Baseline in Phosphatidylinositol 3-kinase (PI3Kδ)/Akt/Mammalian Target of Rapamycin (mTOR) Pathway Activation as a Measure of PI3Kδ Pathway Activity | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines | 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. | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment | 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. | 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) |
| Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib | Weeks 4, 12, and 24 |
| Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure | 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. | Study GS-US-312-0116 or GS-US-312-0117 Baseline; Weeks 24 and 48 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| University of California, San Diego - Moores Cancer Center | La Jolla | California | 92093 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| UCLA | Santa Monica | California | 90404 | United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Collaborative Research Group | Boynton Beach | Florida | 33435 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Willamette Valley Cancer Center | Springfield | Oregon | 97477 | United States |
| Northwest Cancer Specialists, PC | Tualatin | Oregon | 97062 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Cancer Care Network of South Texas | San Antonio | Texas | 78217 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1024 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker | Erlangen | 91052 | Germany |
| Ospedale San Raffaele S.r.l. | Milan | 20132 | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Dorset County Hospital | Dorchester | DT1 2JY | United Kingdom |
| Northwick Park Hospital | Harrow | HA1 3UJ | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Hammersmith Hospital | London | W12 0NN | United Kingdom |
| Princess Royal University Hospital | Orpington | BR6 8ND | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
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. |
| FG002 | 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. |
| FG003 | 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. |
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| NOT COMPLETED |
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| Study GS-US-312-0117 |
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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. Baseline data presented were collected at the beginning of Study GS-US-312-0116.
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| ID | Title | Description |
|---|---|---|
| BG000 | IDL+R to IDL | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 17p Deletion and/or TP53 Mutation Status | Count of Participants | Participants |
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| Immunoglobulin heavy chain variable region (IgHV) Mutation Status | Count of Participants | Participants |
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| Karnofsky Performance Status (KPS) | 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. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Primary | 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 | The TEAEs were defined as events in a given study period that met one of the following criteria:
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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | 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 |
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| Secondary | Overall Response Rate (ORR) | 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Lymph Node Response Rate | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Complete Response (CR) Rate | 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Time to Response (TTR) | TTR was defined as the time interval from start of study therapy to the first documentation of CR or PR. | Participants in the Full Analysis Set who achieved a CR or PR were analyzed. | Posted | Median | Inter-Quartile Range | months | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Duration of Response (DOR) | 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. | Participants in the Full Analysis Set who achieved a CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Best Percent Change in Lymph Node Area | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Splenomegaly Response Rate | 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). | Participants in the Full Analysis Set who had splenomegaly at baseline and at least 1 evaluable postbaseline spleen measurement were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Hepatomegaly Response Rate | 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). | Participants in the Full Analysis Set who had hepatomegaly at baseline and at least 1 evaluable postbaseline liver measurement were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Absolute Lymphocyte Count (ALC) Response Rate | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Platelet Response Rate | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Response Rate | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Neutrophil Response Rate | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | 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. | 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. | Posted | Median | 95% Confidence Interval | months | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 184 |
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| Secondary | Best Change From Baseline in Karnofsky Performance Status (KPS) | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 190 |
| |||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Phosphatidylinositol 3-kinase (PI3Kδ)/Akt/Mammalian Target of Rapamycin (mTOR) Pathway Activation as a Measure of PI3Kδ Pathway Activity | Data were not collected because there was insufficient volume of sample (not enough material) to perform the analysis for any participant. | Posted | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines | 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. | 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. | Posted | Median | Full Range | percentage of baseline | GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months) |
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| Secondary | Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment | 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | 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) |
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| Secondary | Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib | 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. | Posted | Median | Inter-Quartile Range | ng/mL | Weeks 4, 12, and 24 |
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| Secondary | Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Study GS-US-312-0116 or GS-US-312-0117 Baseline; Weeks 24 and 48 |
|
Adverse Events: 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 30 days; All-Cause Mortality: First IDL dose date up to 67.6 months
Only adverse events occurring in participants who enrolled into the extension Study GS-US-312-0117 were included. Adverse events occurring in the parent study, GS-US-312-0116, are reported in ClinicalTrials.gov record NCT01539512.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDL+R to IDL 150 mg | Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received IDL 150 mg 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. | 37 | 71 | 54 | 71 | 70 | 71 |
| EG001 | IDL+R (PD) to IDL 300 mg | Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily. | 3 | 4 | 2 | 4 | 4 | 4 |
| EG002 | Placebo+R (PD) to IDL 150 mg | Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who 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. | 25 | 42 | 34 | 42 | 41 | 42 |
| EG003 | Placebo+R to IDL 150 mg | Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who 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. | 16 | 44 | 32 | 44 | 43 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sepsis pasteurella | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Computerised tomogram thorax abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Jan 23, 2013 | Apr 3, 2019 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Sep 10, 2013 | Apr 3, 2019 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Dec 16, 2013 | Apr 3, 2019 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 4 | May 27, 2014 | Apr 3, 2019 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 5 | Oct 10, 2014 | Apr 3, 2019 | Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 6 | Mar 28, 2016 | Apr 3, 2019 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 7 | Aug 5, 2016 | Apr 3, 2019 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Blinded | Nov 4, 2013 | Apr 3, 2019 | SAP_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Open Label | Jan 26, 2015 | Apr 3, 2019 | SAP_009.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 8 | Oct 24, 2016 | Apr 3, 2019 | Prot_010.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 9 | Sep 21, 2017 | Apr 3, 2019 | Prot_011.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552946 | idelalisib |
Not provided
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Other |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| Not Permitted |
|
| United Kingdom |
|
| Italy |
|
| France |
|
| Germany |
|
| Neither |
|
| Unmutated |
|
| KPS = 50 |
|
| KPS = 60 |
|
| KPS = 70 |
|
| KPS = 80 |
|
| KPS = 90 |
|
| KPS = 100 |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
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. |
|
|
|
|
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. |
|
|
| 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. |
|
|
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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Units |
|---|
| Counts |
|---|
| 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. |
|
|
| OG003 |
| 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. |
|
|
| OG002 | 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. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|