Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01088048
• Collaborator: (none)
• Enrollment: 241
• Locations: 11
• Arms: 10
• Actual Duration (Months): 61.1
• Patients Per Site: 21.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

Condition or Disease	Intervention/Treatment	Phase
Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma	Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine; Drug: Ofatumumab; Drug: Fludarabine; Drug: Everolimus; Drug: Bortezomib; Drug: Chlorambucil; Drug: Lenalidomide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
• Actual Study Start Date: Mar 25, 2010
• Actual Primary Completion Date: Apr 28, 2015
• Actual Study Completion Date: Apr 28, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Idelalisib + Rituximab Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) will receive treatments as follows: Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 intravenously (IV) on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Rituximab; Rituximab administered intravenously; Other Names: Rituxan
Experimental: Idelalisib + Rituximab + Bendamustine Participants with CLL, iNHL and mantle cell lymphoma (MCL) will receive treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Rituximab; Rituximab administered intravenously; Other Names: Rituxan ; Drug: Bendamustine; Bendamustine administered intravenously; Other Names: Treanda
Experimental: Idelalisib + Bendamustine Participants with CLL and iNHL will receive treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Bendamustine; Bendamustine administered intravenously; Other Names: Treanda
Experimental: Idelalisib + Ofatumumab Participants with CLL will receive treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Ofatumumab; Ofatumumab administered intravenously; Other Names: Arzerra
Experimental: Idelalisib + Fludarabine Participants with CLL will receive treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Fludarabine; Fludarabine administered orally; Other Names: Fludara
Experimental: Idelalisib + Everolimus Participants with MCL will receive treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Everolimus; Everolimus administered orally twice daily until disease progression; Other Names: Afinitor RAD-001
Experimental: Idelalisib + Bortezomib Participants with MCL will receive treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Bortezomib; Bortezomib administered as a subcutaneous injection; Other Names: Velcade codenamed PS-341
Experimental: Idelalisib + Chlorambucil Participants with CLL will receive treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Chlorambucil; Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.; Other Names: Leukeran
Experimental: Idelalisib + Rituximab + Chlorambucil Participants with CLL will receive treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Rituximab; Rituximab administered intravenously; Other Names: Rituxan ; Drug: Chlorambucil; Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.; Other Names: Leukeran
Experimental: Idelalisib + Rituximab + Lenalidomide Participants with CLL and iNHL will receive treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles	Drug: Idelalisib; Idelalisib tablet administered orally; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Rituximab; Rituximab administered intravenously; Other Names: Rituxan ; Drug: Lenalidomide; Lenalidomide administered orally; Other Names: Revlimid

Outcome Measures

Primary Outcome Measures

1. Duration of Exposure to IDELA [First dose date up to 12 months]

   Duration of exposure to IDELA was summarized using descriptive statistics.

2. Toxicity of Administration of IDELA [First dose date up to 5 years]

   Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02

Secondary Outcome Measures

1. Overall Response Rate [Up to 5 years]

   Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). The response definitions were based on the following standard criteria established for each indication: CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008 iNHL & MCL: Cheson, 2007

2. Duration of Response [Up to 5 years]

   Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.

3. Time to Response [Up to 5 years]

   Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.

4. Progression-free Survival [Up to 5 years]

   Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause. The response definitions were based on the following standard criteria established for each indication: CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008 iNHL & MCL: Cheson, 2007

5. Overall Survival [Up to 5 years]

   Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.

6. Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5) [Predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 0; predose, 1.5 hours postdose at Weeks 4, 12, and 24]

7. Plasma Concentration of IDELA (Cohort 4) [Predose at Week 0; predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 4; predose, 1.5 hours postdose at Week 12; and predose, 1.5 hours postdose at Week 24]

8. Plasma Concentration of IDELA (Cohort 6) [Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24]

9. Plasma Concentration of IDELA (Cohort 7) [Predose, 1.5 hours postdose at Weeks 0, 5 and 13]

10. Sub-study: Plasma Concentration of IDELA (Cohorts 1-4) [pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose]

11. Plasma Concentration of Bendamustine [Predose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 hours postdose at Week 0]

12. Plasma Concentration of Everolimus [Predose, 1.5 hours postdose at Weeks 0 and 4]

13. Plasma Concentration of Lenalidomide [Predose, 1.5 hours postdose at Week 1 and predose at Week 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Age ≥ 18

• Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen)

• Disease status requirement:

• For CLL patients, symptomatic disease that mandates treatment as defined by the International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) 2008 criteria

• For indolent NHL and MCL patients, measurable disease by CT scan defined as at least 1 lesion that measures > 2 cm in a single dimension

• WHO performance status of ≤ 2

• For men and women of child-bearing potential, willing to use adequate contraception (ie, latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.

• For Cohort 7 only: Women of child bearing potential must have 2 negative pregnancy tests prior to starting lenalidomide.

• Able to provide written informed consent

Key Exclusion Criteria:

• Is not a good candidate to receive any of the drugs administered in the study for a given disease (idelalisib, bendamustine, rituximab, ofatumumab, fludarabine, everolimus, bortezomib, or chlorambucil), according to the clinical judgment of the investigator

• Patients with atypical immunophenotype with t(11:14) translocation or cyclin D1 over-expression (CLL patients only)

• Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to the baseline disease status tests

• Had treatment with a short course of corticosteroids for symptom relief within 1-week prior to the baseline disease status tests

• Has had an allogeneic hematopoietic stem cell transplant

• Has known active central nervous system involvement of the malignancy

• Is pregnant or nursing

• Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the investigator

• Has absolute neutrophil count (ANC) < 1000/µL, unless it is related to underlying CLL, MCL or indolent NHL, the latter documented by > 50% infiltration of bone marrow by tumor cells

• Has platelet count < 75000/µL, unless it is related to underlying CLL, MCL, or iNHL, the latter documented by > 50% infiltration of bone marrow by tumor cells

• Has serum creatinine ≥ 2.0 mg/dL

• For Cohort 7 only: Has creatinine clearance < 60 mL/min

• Has serum bilirubin ≥ 2 mg/dL (unless due to Gilbert's syndrome) for patients with iNHL or CLL; for patients with MCL, serum bilirubin ≥ 1.5 x upper limit of normal

• Has serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥ 2 x upper limit of normal

• Has Child-Pugh Class B or C hepatic impairment

• Has a positive test for HIV antibodies

• Has active hepatitis B or C (confirmed by RNA test). Patients with serologic evidence of prior exposure are eligible.

• Prior treatment with idelalisib

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clearview Cancer Institute	Huntsville	Alabama	United States	35805
2	UCLA	Los Angeles	California	United States	90024
3	Stanford Cancer Center	Palo Alto	California	United States	94304-5548
4	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
5	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
6	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
7	Weill Medical College of Cornell	New York	New York	United States	10021
8	Willamette Valley Cancer Institute and Research Center	Springfield	Oregon	United States	97477
9	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
10	MD Anderson Cancer	Houston	Texas	United States	77030
11	North Star Lodge Cancer Center	Yakima	Washington	United States	98902

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT01088048
• Other Study ID Numbers: 101-07
• First Posted: Mar 17, 2010
• Last Update Posted: Mar 18, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gilead Sciences: phosphatidylinositol 3-kinase; Ofatumumab; indolent non-Hodgkin lymphoma (iNHL)
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell; Rituximab; Fludarabine; Lenalidomide; Everolimus; Bortezomib; Bendamustine Hydrochloride; Ofatumumab; Idelalisib; Chlorambucil

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at study sites in United States. The first participant was screened on 25 March 2010. The last study visit occurred on 28 April 2015.
Pre-assignment Detail	277 participants were screened. Per prespecified analysis, participants were grouped by disease (chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma, mantle cell lymphoma) and by treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) received treatments as follows: Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 intravenously (IV) on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with mantle cell lymphoma (MCL) received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Period Title: Overall Study
STARTED	51	51	18	18	33	21	12	15	15	7
Participants With CLL	19	18	0	0	15	21	12	15	14	1
Participants With Indolent NHL	32	33	0	0	14	0	0	0	1	6
Participants With MCL	0	0	18	18	4	0	0	0	0	0
COMPLETED	29	24	4	4	16	10	6	10	8	3
NOT COMPLETED	22	27	14	14	17	11	6	5	7	4

Baseline Characteristics

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide	Total
Arm/Group Description	Participants with CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles	Total of all reporting groups
Overall Participants	51	51	18	18	33	21	12	15	15	7	241
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (10.1)	61 (11.2)	69 (7.1)	72 (6.0)	60 (8.3)	66 (9.7)	69 (7.1)	63 (7.8)	68 (10.0)	61 (8.3)	64 (9.9)
Sex: Female, Male (Count of Participants)
Female	16 31.4%	21 41.2%	7 38.9%	3 16.7%	12 36.4%	6 28.6%	4 33.3%	1 6.7%	4 26.7%	2 28.6%	76 31.5%
Male	35 68.6%	30 58.8%	11 61.1%	15 83.3%	21 63.6%	15 71.4%	8 66.7%	14 93.3%	11 73.3%	5 71.4%	165 68.5%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian	42 82.4%	45 88.2%	16 88.9%	14 77.8%	29 87.9%	20 95.2%	8 66.7%	14 93.3%	15 100%	6 85.7%	209 86.7%
Black or African American	2 3.9%	3 5.9%	0 0%	0 0%	1 3%	0 0%	1 8.3%	1 6.7%	0 0%	1 14.3%	9 3.7%
Asian	5 9.8%	1 2%	1 5.6%	2 11.1%	1 3%	0 0%	1 8.3%	0 0%	0 0%	0 0%	11 4.6%
Other	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%	1 0.4%
Not Reported	2 3.9%	2 3.9%	1 5.6%	2 11.1%	2 6.1%	0 0%	2 16.7%	0 0%	0 0%	0 0%	11 4.6%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	0 0%	2 3.9%	0 0%	1 5.6%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	4 1.7%
Not Hispanic or Latino	51 100%	49 96.1%	18 100%	17 94.4%	31 93.9%	21 100%	11 91.7%	14 93.3%	15 100%	7 100%	234 97.1%
Missing	0 0%	0 0%	0 0%	0 0%	2 6.1%	0 0%	1 8.3%	0 0%	0 0%	0 0%	3 1.2%

Outcome Measures

1. Primary Outcome

Title	Duration of Exposure to IDELA
Description	Duration of exposure to IDELA was summarized using descriptive statistics.
Time Frame	First dose date up to 12 months

Outcome Measure Data

Analysis Population Description

The ITT analysis set included participants who received at least 1 dose of study drug (idelalisib or combination drugs). Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	51	51	18	18	33	21	12	15	15	7
Mean (Standard Deviation) [months]	8.1 (3.74)	7.6 (3.96)	4.2 (3.92)	5.1 (3.90)	8.0 (4.16)	8.3 (4.03)	8.9 (3.57)	8.8 (3.76)	8.7 (3.01)	7.7 (4.78)

2. Primary Outcome

Title	Toxicity of Administration of IDELA
Description	Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02
Time Frame	First dose date up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	51	51	18	18	33	21	12	15	15	7
Number [percentage of participants]	100.0 196.1%	100.0 196.1%	100.0 555.6%	83.33 462.9%	100.0 303%	100.0 476.2%	100.0 833.3%	100.0 666.7%	100.0 666.7%	100.0 1428.6%

3. Secondary Outcome

Title	Overall Response Rate
Description	Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). The response definitions were based on the following standard criteria established for each indication: CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008 iNHL & MCL: Cheson, 2007
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	51	51	18	18	33	21	12	15	15	7
Number (95% Confidence Interval) [percentage of participants]	78.4 153.7%	84.3 165.3%	44.4 246.7%	61.1 339.4%	81.8 247.9%	71.4 340%	91.7 764.2%	66.7 444.7%	93.3 622%	71.4 1020%

4. Secondary Outcome

Title	Duration of Response
Description	Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set with available data were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	40	43	8	11	27	15	11	10	14	5
Median (95% Confidence Interval) [months]	NA	NA	5.6	9.3	NA	NA	NA	NA	NA	NA

5. Secondary Outcome

Title	Time to Response
Description	Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set with available data were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	40	43	8	11	27	15	11	10	14	5
Median (Inter-Quartile Range) [months]	1.9	1.9	1.9	1.9	1.9	1.9	1.9	1.9	1.9	3.0

6. Secondary Outcome

Title	Progression-free Survival
Description	Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause. The response definitions were based on the following standard criteria established for each indication: CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008 iNHL & MCL: Cheson, 2007
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	51	51	18	18	33	21	12	15	15	7
Median (95% Confidence Interval) [months]	NA	NA	4.3	8.1	NA	NA	NA	NA	NA	NA

7. Secondary Outcome

Title	Overall Survival
Description	Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).

Arm/Group Title	Idelalisib + Rituximab	Idelalisib + Bendamustine	Idelalisib + Everolimus	Idelalisib + Bortezomib	Idelalisib + Rituximab + Bendamustine	Idelalisib + Ofatumumab	Idelalisib + Fludarabine	Idelalisib + Chlorambucil	Idelalisib + Rituximab + Chlorambucil	Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2	Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle	Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle	Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))	Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6	Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12	Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	51	51	18	18	33	21	12	15	15	7
Median (95% Confidence Interval) [months]	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA

8. Secondary Outcome

Title	Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5)
Time Frame	Predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 0; predose, 1.5 hours postdose at Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

The pharmacokinetic (PK) analysis set included data from participants in the ITT analysis set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. Per prespecified analysis, data were summarized for participants in Cohort 1a 1b, who received idelalisib 100 mg and for participants in Cohorts 2a, 2b, 3a, 3b, 3c, 3d, 3e, 3f, 3g 5a, 5b, and 5c who received idelalisib 150 mg.

Arm/Group Title	Idelalisib 100 mg (Cohort 1)	Idelalisib 150 mg (Cohorts 2 and 3)	Idelalisib 150 mg (Cohort 5)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 1 (subcohort 1a and 1b) who received the treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycle 1 - 6	Participants analyzed for this group included participants from Cohort 2a, 2b, 3a, 3b, 3c, 3e, 3f, 3g who received the treatments as follows: Cohort 2a: IDELA 150 mg orally (po) BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2 Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6 Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, C1 - C6 + bendamustine 90 mg/m^2 (Cohort 3a only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3b only) IV on D1 & D2, C1 - C6 Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12)) Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m^2 po D1 - D5, C1 - C6 Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2 Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 (cohort 3f only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3g only) IV, D1 & D2, C1 - C6 C= Cycle D= Day Cycle length= 28 days	Participants analyzed for this group included participants from Cohort 5 (subcohorts 5a, 5b, and 5c) who received the treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6
Measure Participants	24	123	45
Pre-dose (Week 0)	0.4 (2.16)	68.8 (396.94)	0.0 (0.0)
0.5 hr post-dose (Week 0)	437.6 (380.08)	1231.4 (1238.20)	1380.0
1.0 hr post-dose (Week 0)	1022.4 (652.92)	1789.3 (1162.31)	1600.0
1.5 hr post-dose (Week 0)	1434.0 (835.25)	2017.3 (1241.96)	1564.7 (983.46)
2.0 hr post-dose (Week 0)	1282.7 (789.24)	1732.8 (744.87)	1400.0
3.0 hr post-dose (Week 0)	1001.0 (633.99)	1296.1 (509.80)	1170.0
4.0 hr post-dose (Week 0)	788.4 (629.67)	910.0 (420.79)	795.0
6.0 hr post-dose (Week 0)	523.7 (418.80)	486.0 (276.75)	517.0
Pre-dose (Week 4)	416.5 (636.01)	364.1 (341.84)	408.0 (699.35)
1.5 hr post-dose (Week 4)	1297.2 (681.43)	1808.1 (931.67)	1877.9 (859.74)
Pre-dose (Week 12)	361.9 (580.70)	351.4 (389.78)	433.9 (529.79)
1.5 hr post-dose (Week 12)	1309.5 (750.50)	1883.0 (973.26)	1426.8 (917.02)
Pre-dose (Week 24)	369.9 (461.67)	419.7 (359.03)	549.1 (622.95)
1.5 hr post-dose (Week 24)	1061.6 (567.90)	1840.1 (1035.91)	885.6 (568.81)

9. Secondary Outcome

Title	Plasma Concentration of IDELA (Cohort 4)
Time Frame	Predose at Week 0; predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 4; predose, 1.5 hours postdose at Week 12; and predose, 1.5 hours postdose at Week 24

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 4a, 4b who received idelalisib 150mg.

Arm/Group Title	Idelalisib 150 mg (Cohort 4)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 4 (subcohorts 4a and 4b) who received the treatments as follows: Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6
Measure Participants	18
Pre-dose (Week 0)	0.0 (0.0)
Pre-dose (Week 4)	0.0 (0.0)
0.5 hr post-dose (Week 4)	1119.5 (1513.99)
1.0 hr post-dose (Week 4)	994.5 (601.75)
1.5 hr post-dose (Week 4)	1758.2 (1414.07)
2.0 hr post-dose (Week 4)	737.0 (108.89)
3.0 hr post-dose (Week 4)	605.0 (18.38)
4.0 hr post-dose (Week 4)	547.0 (158.39)
6.0 hr post-dose (Week 4)	524.0 (404.47)
Pre-dose (Week 12)	401.9 (344.93)
1.5 hr post-dose (Week 12)	2018.2 (1703.98)
Pre-dose (Week 24)	752.5 (967.91)
1.5 hr post-dose (Week 24)	2251.1 (1744.44)

10. Secondary Outcome

Title	Plasma Concentration of IDELA (Cohort 6)
Time Frame	Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 6a, 6b who received idelalisib 150mg.

Arm/Group Title	Idelalisib 150 mg (Cohort 6)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 6 (subcohorts 6a and 6b) who received the treatments as follows Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12 Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12
Measure Participants	30
Pre-dose (Week 0)	0.0 (0.0)
1.5 hr post-dose (Week 0)	1930.7 (1220.87)
Pre-dose (Week 4)	530.8 (563.59)
1.5 hr post-dose (Week 4)	1869.8 (1001.39)
Pre-dose (Week 12)	677.9 (940.94)
1.5 hr post-dose (Week 12)	1733.0 (941.94)
Pre-dose (Week 24)	346.8 (377.84)
1.5 hr post-dose (Week 24)	1710.7 (1235.08)

11. Secondary Outcome

Title	Plasma Concentration of IDELA (Cohort 7)
Time Frame	Predose, 1.5 hours postdose at Weeks 0, 5 and 13

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 7a, 7b, 7c who received idelalisib 150mg.

Arm/Group Title	Idelalisib 150 mg (Cohort 7)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 7 (subcohorts 7a, 7b, and 7c) who received the treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	7
Pre-dose (Week 0)	NA (NA)
1.5 hr post-dose (Week 0)	1603.1 (1196.78)
Pre-dose (Week 5)	20.7 (50.13)
1.5 hr post-dose (Week 5)	1621.3 (663.80)
Pre-dose (Week 13)	354.8 (278.62)
1.5 hr post-dose (Week 13)	592.7 (597.52)

12. Secondary Outcome

Title	Sub-study: Plasma Concentration of IDELA (Cohorts 1-4)
Time Frame	pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose

Outcome Measure Data

Analysis Population Description

Participants with CLL or iNHL from the PK Analysis Set in Cohorts 1, 2, 3, and 4 who participated in the PK substudy were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 1a, 1b who received idelalisib 100mg and Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b who received idelalisib 150 mg in the PK substudy.

Arm/Group Title	Idelalisib 100 mg (Cohort 1a, 1b)	Idelalisib 150 mg (Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 1 who received the treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6	Participants included for analysis received treatments as follows: Cohort 2a: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2 Cohort 2b: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6 Cohorts 3a and 3b: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, C1 - C6 + bendamustine 90 mg/m^2 (Cohort 3a only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3b only) IV on D1 & D2, C1 - C6 Cohort 3c: IDELA 150 mg po BID, D1 - D28 of each cycle + ofatumumab 12 doses (300 mg (D1 or D2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12)) Cohort 3d: IDELA 150 mg po BID, D1 - D28 of each cycle + fludarabine 40 mg/m^2 po D1 - D5, C1 - C6 Cohort 3e: IDELA 150 mg po BID, D1 - D28 of each cycle + rituximab 375 mg/m^2 IV on D1, D8, D15, & D22, C1 & C2 Cohorts 3f and 3g: IDELA 150 mg po BID, D1 - D28 of each cycle + bendamustine 90 mg/m^2 (Cohort 3f only) IV, D1 & D2, C1 - C6 + bendamustine 70 mg/m^2 (Cohort 3g only) IV, D1 & D2, C1 - C6 Cohort 4a: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2 D1) + rituximab 375 mg/m^2 IV, D1, D8, D15, & D22, C1 & C2 Cohort 4b: IDELA 150 mg po BID, D1 - D28 of each cycle (starting C2, D3) + bendamustine 90 mg/m^2 IV, D1 & D2, C1 - C6 C= Cycle D= Day Cycle length= 28 days
Measure Participants	7	24
Pre-dose	1.5 (4.01)	0.0 (0.0)
0.5 hr post-dose	437.6 (380.08)	1222.1 (1224.95)
1.0 hr post-dose	1022.4 (652.92)	1723.1 (1140.00)
1.5 hr post-dose	1264.7 (868.41)	1599.2 (746.58)
2.0 hr post-dose	1282.7 (789.24)	1646.2 (766.31)
3.0 hr post-dose	1001.0 (633.99)	1238.5 (524.77)
4.0 hr post-dose	788.4 (629.67)	879.8 (416.25)
6.0 hr post-dose	523.7 (418.80)	489.3 (277.82)

13. Secondary Outcome

Title	Plasma Concentration of Bendamustine
Time Frame	Predose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 hours postdose at Week 0

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c who received bendamustine.

Arm/Group Title	Bendamustine (Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c)
Arm/Group Description	Participants included for analysis received treatments as follows: Cohort 1b: IDELA 100 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3a: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 3f: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg po BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 5c: IDELA 150 mg po BID on Days 1 - 28 + rituximab 375 mg/m^2 IV on Day 1, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2, Cycles 1 - 6 (Cycle length= 28 days)
Measure Participants	19
Pre-dose (Week 0)	NA (NA)
0.25 hr post-dose (Week 0)	3484.1 (2617.17)
0.5 hr post-dose (Week 0)	4694.7 (3570.78)
0.75 hr post-dose (Week 0)	3433.2 (2991.15)
1.0 hr post-dose (Week 0)	2847.2 (2462.90)
1.25 hr post-dose (Week 0)	1916.4 (1551.50)
1.5 hr post-dose (Week 0)	1211.2 (1093.74)
2.0 hr post-dose (Week 0)	514.0 (489.76)
3.0 hr post-dose (Week 0)	463.4 (1529.30)
4.0 hr post-dose (Week 0)	78.5 (238.30)
5.0 hr post-dose (Week 0)	15.3 (36.79)
6.0 hr post-dose (Week 0)	4.4 (6.58)

14. Secondary Outcome

Title	Plasma Concentration of Everolimus
Time Frame	Predose, 1.5 hours postdose at Weeks 0 and 4

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Data were summarized for participants in Cohort 5a who received everolimus.

Arm/Group Title	Everolimus (Cohort 5a)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 5 (subcohort 5a) who received the treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle
Measure Participants	6
Pre-dose (Week 0)	NA (NA)
1.5 hr post-dose (Week 0)	93.0 (63.50)
Pre-dose (Week 4)	3.0 (3.79)
1.5 hr post-dose (Week 4)	56.3 (67.48)

15. Secondary Outcome

Title	Plasma Concentration of Lenalidomide
Time Frame	Predose, 1.5 hours postdose at Week 1 and predose at Week 5

Outcome Measure Data

Analysis Population Description

Participants in the PK analysis set with available data were analyzed. Per prespecified analysis, data were summarized for participants in Cohort 7a, 7b, 7c who received lenalidomide.

Arm/Group Title	Lenalidomide (Cohort 7a, 7b, 7c)
Arm/Group Description	Participants analyzed for this group included participants from Cohort 7 (subcohorts 7a, 7b, and 7c) who received the treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
Measure Participants	7
Pre-dose (Week 1)	NA (NA)
1.5 hr post-dose (Week 1)	51.6 (31.77)
Pre-dose (Week 5)	NA (NA)

Adverse Events

Time Frame	First dose date up to 5 years
Adverse Event Reporting Description	The ITT analysis set included participants who received at least 1 dose of study drug (IDELA or combination drugs). Per prespecified analysis, participants were grouped by disease (CLL, iNHL, MCL) and by treatment regimen (cohort).
Arm/Group Title	Idelalisib + Rituximab		Idelalisib + Bendamustine		Idelalisib + Everolimus		Idelalisib + Bortezomib		Idelalisib + Rituximab + Bendamustine		Idelalisib + Ofatumumab		Idelalisib + Fludarabine		Idelalisib + Chlorambucil		Idelalisib + Rituximab + Chlorambucil		Idelalisib + Rituximab + Lenalidomide
Arm/Group Description	Participants with chronic CLL and iNHL received treatments as follows: Cohort 1a: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15 & 22, Cycles 1 & 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2		Participants with CLL and iNHL received treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6		Participants with MCL received treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle		Participants with MCL received treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle		Participants with CLL, iNHL and MCL received treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6		Participants with CLL received treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))		Participants with CLL received treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6		Participants with CLL received treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12		Participants with CLL received treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12		Participants with CLL and iNHL received treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) and Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of the first cycle and Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily starting on Days 8 - 28 of Cycle 1 (35 days) and Days 1 - 21 of the next five 28-day cycles
All Cause Mortality
	Idelalisib + Rituximab		Idelalisib + Bendamustine		Idelalisib + Everolimus		Idelalisib + Bortezomib		Idelalisib + Rituximab + Bendamustine		Idelalisib + Ofatumumab		Idelalisib + Fludarabine		Idelalisib + Chlorambucil		Idelalisib + Rituximab + Chlorambucil		Idelalisib + Rituximab + Lenalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/51 (2%)		6/51 (11.8%)		4/18 (22.2%)		3/18 (16.7%)		1/33 (3%)		4/21 (19%)		2/12 (16.7%)		0/15 (0%)		3/15 (20%)		2/7 (28.6%)
Serious Adverse Events
	Idelalisib + Rituximab		Idelalisib + Bendamustine		Idelalisib + Everolimus		Idelalisib + Bortezomib		Idelalisib + Rituximab + Bendamustine		Idelalisib + Ofatumumab		Idelalisib + Fludarabine		Idelalisib + Chlorambucil		Idelalisib + Rituximab + Chlorambucil		Idelalisib + Rituximab + Lenalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/51 (39.2%)		37/51 (72.5%)		14/18 (77.8%)		6/18 (33.3%)		17/33 (51.5%)		12/21 (57.1%)		9/12 (75%)		9/15 (60%)		8/15 (53.3%)		5/7 (71.4%)
Blood and lymphatic system disorders
Anaemia	0/51 (0%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Autoimmune haemolytic anaemia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Coombs positive haemolytic anaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Febrile neutropenia	3/51 (5.9%)		5/51 (9.8%)		2/18 (11.1%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		4/15 (26.7%)		2/15 (13.3%)		0/7 (0%)
Immune thrombocytopenic purpura	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neutropenia	0/51 (0%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pancytopenia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Thrombocytopenia	1/51 (2%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Cardiac disorders
Atrial fibrillation	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cardiac arrest	1/51 (2%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cardiac failure	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Supraventricular tachycardia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Endocrine disorders
Endocrine disorder	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Eye disorders
Retinal detachment	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Uveitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastrointestinal disorders
Abdominal pain	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Colitis	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		2/15 (13.3%)		1/15 (6.7%)		1/7 (14.3%)
Colitis ischaemic	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Colitis microscopic	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Diarrhoea	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		1/18 (5.6%)		2/33 (6.1%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		2/15 (13.3%)		0/7 (0%)
Dysphagia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastrointestinal haemorrhage	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Gingival bleeding	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Intestinal obstruction	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Large intestinal ulcer	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Mouth haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Nausea	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neutropenic colitis	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Peptic ulcer	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rectal haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Stomatitis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vomiting	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
General disorders
Asthenia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Chest pain	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Fatigue	0/51 (0%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Generalised oedema	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Mucosal inflammation	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Multi-organ failure	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pyrexia	1/51 (2%)		10/51 (19.6%)		1/18 (5.6%)		1/18 (5.6%)		5/33 (15.2%)		2/21 (9.5%)		1/12 (8.3%)		1/15 (6.7%)		0/15 (0%)		2/7 (28.6%)
Hepatobiliary disorders
Cholecystitis	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cholecystitis acute	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cholecystitis chronic	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hepatic failure	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Hepatitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Immune system disorders
Hypersensitivity	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Infections and infestations
Aspergillus infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Atypical pneumonia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Bacteraemia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Bacterial infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Bronchiolitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Bronchitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Bronchopulmonary aspergillosis	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Candida infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cellulitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Clostridium difficile colitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Clostridium difficile infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cytomegalovirus gastrointestinal infection	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cytomegalovirus infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cytomegalovirus viraemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Diverticulitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Encephalitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Enterococcal bacteraemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Escherichia bacteraemia	0/51 (0%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Escherichia sepsis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Folliculitis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastroenteritis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastroenteritis salmonella	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Groin abscess	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Herpes zoster	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Herpes zoster disseminated	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Herpes zoster pharyngitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Human herpesvirus 6 infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Listeria sepsis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Listeriosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Lung infection	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Mycobacterium avium complex infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Neutropenic sepsis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Ophthalmic herpes zoster	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Perirectal abscess	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pneumocystis jirovecii pneumonia	0/51 (0%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		2/15 (13.3%)		1/15 (6.7%)		0/7 (0%)
Pneumonia	4/51 (7.8%)		10/51 (19.6%)		2/18 (11.1%)		0/18 (0%)		1/33 (3%)		3/21 (14.3%)		1/12 (8.3%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Pneumonia bacterial	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Pneumonia fungal	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Pneumonia haemophilus	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pneumonia influenzal	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pseudomonal bacteraemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Sepsis	0/51 (0%)		4/51 (7.8%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Septic shock	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Staphylococcal bacteraemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Streptococcal bacteraemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tooth infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Upper respiratory tract infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Urinary tract infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vaginal infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Viral upper respiratory tract infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Injury, poisoning and procedural complications
Fall	1/51 (2%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pelvic fracture	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Subdural haematoma	1/51 (2%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Investigations
Alanine aminotransferase increased	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		2/7 (28.6%)
Aspartate aminotransferase increased	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		2/7 (28.6%)
Blood bilirubin increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Blood lactate dehydrogenase increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		2/7 (28.6%)
Hepatic enzyme increased	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Transaminases increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Weight decreased	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Failure to thrive	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypercalcaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyperglycaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyperkalaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hyperuricaemia	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypoglycaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypokalaemia	0/51 (0%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyponatraemia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Lactic acidosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tumour lysis syndrome	0/51 (0%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Myalgia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rhabdomyolysis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Renal cell carcinoma	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Nervous system disorders
Cerebral ischaemia	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cerebrovascular accident	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dizziness	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Lethargy	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Normal pressure hydrocephalus	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Syncope	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Psychiatric disorders
Depression	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Suicidal ideation	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Renal and urinary disorders
Acute kidney injury	2/51 (3.9%)		0/51 (0%)		3/18 (16.7%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Hydronephrosis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Obstructive uropathy	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Urinary tract obstruction	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Reproductive system and breast disorders
Pelvic pain	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vaginal haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Bronchial secretion retention	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Bronchiectasis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Epistaxis	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypoxia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Organising pneumonia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pleural effusion	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pleuritic pain	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Pneumonitis	1/51 (2%)		2/51 (3.9%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pulmonary embolism	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pulmonary haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Respiratory distress	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Respiratory failure	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Skin and subcutaneous tissue disorders
Angioedema	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Drug eruption	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Erythema multiforme	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		3/33 (9.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash erythematous	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash maculo-papular	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Skin ulcer	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vascular disorders
Deep vein thrombosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypotension	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Orthostatic hypotension	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Idelalisib + Rituximab		Idelalisib + Bendamustine		Idelalisib + Everolimus		Idelalisib + Bortezomib		Idelalisib + Rituximab + Bendamustine		Idelalisib + Ofatumumab		Idelalisib + Fludarabine		Idelalisib + Chlorambucil		Idelalisib + Rituximab + Chlorambucil		Idelalisib + Rituximab + Lenalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/51 (100%)		51/51 (100%)		18/18 (100%)		15/18 (83.3%)		33/33 (100%)		21/21 (100%)		12/12 (100%)		15/15 (100%)		15/15 (100%)		7/7 (100%)
Blood and lymphatic system disorders
Anaemia	6/51 (11.8%)		13/51 (25.5%)		5/18 (27.8%)		5/18 (27.8%)		4/33 (12.1%)		3/21 (14.3%)		3/12 (25%)		3/15 (20%)		4/15 (26.7%)		0/7 (0%)
Coombs positive haemolytic anaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Eosinophilia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Febrile neutropenia	0/51 (0%)		3/51 (5.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Hypoglobulinaemia	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Iron deficiency anaemia	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Leukopenia	3/51 (5.9%)		6/51 (11.8%)		2/18 (11.1%)		2/18 (11.1%)		4/33 (12.1%)		0/21 (0%)		0/12 (0%)		4/15 (26.7%)		0/15 (0%)		0/7 (0%)
Lymphadenopathy	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Lymphocytosis	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Lymphopenia	0/51 (0%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neutropenia	15/51 (29.4%)		27/51 (52.9%)		7/18 (38.9%)		4/18 (22.2%)		13/33 (39.4%)		6/21 (28.6%)		6/12 (50%)		9/15 (60%)		7/15 (46.7%)		2/7 (28.6%)
Pancytopenia	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Thrombocytopenia	4/51 (7.8%)		14/51 (27.5%)		11/18 (61.1%)		4/18 (22.2%)		3/33 (9.1%)		3/21 (14.3%)		1/12 (8.3%)		5/15 (33.3%)		3/15 (20%)		0/7 (0%)
Cardiac disorders
Angina pectoris	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Atrial fibrillation	1/51 (2%)		1/51 (2%)		3/18 (16.7%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Cardiac failure congestive	0/51 (0%)		2/51 (3.9%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Cardiomyopathy	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Palpitations	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		3/12 (25%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Pulseless electrical activity	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Sinus tachycardia	0/51 (0%)		3/51 (5.9%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tachycardia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Ear and labyrinth disorders
Ear pain	2/51 (3.9%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vertigo	5/51 (9.8%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Eye disorders
Cataract	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Dry eye	1/51 (2%)		0/51 (0%)		2/18 (11.1%)		1/18 (5.6%)		3/33 (9.1%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		2/7 (28.6%)
Eye irritation	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Eyelid thickening	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Lacrimation increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		3/7 (42.9%)
Periorbital oedema	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vision blurred	3/51 (5.9%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Visual impairment	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vitreous floaters	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastrointestinal disorders
Abdominal discomfort	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Abdominal distension	2/51 (3.9%)		1/51 (2%)		2/18 (11.1%)		2/18 (11.1%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Abdominal hernia	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Abdominal pain	10/51 (19.6%)		6/51 (11.8%)		1/18 (5.6%)		3/18 (16.7%)		3/33 (9.1%)		2/21 (9.5%)		1/12 (8.3%)		1/15 (6.7%)		3/15 (20%)		1/7 (14.3%)
Abdominal pain lower	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Abdominal pain upper	3/51 (5.9%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Abdominal tenderness	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Anal haemorrhage	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Anal pruritus	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Aphthous stomatitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Colitis	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Constipation	5/51 (9.8%)		11/51 (21.6%)		2/18 (11.1%)		3/18 (16.7%)		8/33 (24.2%)		4/21 (19%)		2/12 (16.7%)		2/15 (13.3%)		6/15 (40%)		6/7 (85.7%)
Diarrhoea	20/51 (39.2%)		14/51 (27.5%)		9/18 (50%)		7/18 (38.9%)		12/33 (36.4%)		11/21 (52.4%)		6/12 (50%)		6/15 (40%)		8/15 (53.3%)		2/7 (28.6%)
Dry mouth	1/51 (2%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dyspepsia	1/51 (2%)		9/51 (17.6%)		1/18 (5.6%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Dysphagia	3/51 (5.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Faeces soft	1/51 (2%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Flatulence	3/51 (5.9%)		2/51 (3.9%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Gastritis	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gastrooesophageal reflux disease	1/51 (2%)		5/51 (9.8%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Gingival bleeding	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Gingival pain	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Glossitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Glossodynia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Haematochezia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Large intestine polyp	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Lip blister	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Mouth ulceration	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Nausea	17/51 (33.3%)		19/51 (37.3%)		2/18 (11.1%)		3/18 (16.7%)		14/33 (42.4%)		6/21 (28.6%)		4/12 (33.3%)		4/15 (26.7%)		6/15 (40%)		4/7 (57.1%)
Noninfective gingivitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Oesophagitis	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Oral dysaesthesia	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Oral pain	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Proctitis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Retching	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Stomatitis	4/51 (7.8%)		4/51 (7.8%)		2/18 (11.1%)		1/18 (5.6%)		2/33 (6.1%)		1/21 (4.8%)		0/12 (0%)		2/15 (13.3%)		0/15 (0%)		2/7 (28.6%)
Toothache	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		2/15 (13.3%)		0/15 (0%)		0/7 (0%)
Vomiting	5/51 (9.8%)		6/51 (11.8%)		2/18 (11.1%)		1/18 (5.6%)		6/33 (18.2%)		3/21 (14.3%)		3/12 (25%)		4/15 (26.7%)		1/15 (6.7%)		2/7 (28.6%)
General disorders
Asthenia	5/51 (9.8%)		4/51 (7.8%)		3/18 (16.7%)		2/18 (11.1%)		2/33 (6.1%)		1/21 (4.8%)		2/12 (16.7%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Catheter site pain	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Chest discomfort	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		2/15 (13.3%)		0/7 (0%)
Chest pain	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		1/18 (5.6%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Chills	8/51 (15.7%)		11/51 (21.6%)		4/18 (22.2%)		2/18 (11.1%)		4/33 (12.1%)		3/21 (14.3%)		0/12 (0%)		6/15 (40%)		1/15 (6.7%)		1/7 (14.3%)
Face oedema	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Fatigue	18/51 (35.3%)		24/51 (47.1%)		5/18 (27.8%)		4/18 (22.2%)		12/33 (36.4%)		4/21 (19%)		5/12 (41.7%)		4/15 (26.7%)		5/15 (33.3%)		4/7 (57.1%)
Gait disturbance	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Inflammation	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Influenza like illness	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Infusion site pain	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		3/33 (9.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Injection site discomfort	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Injection site erythema	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Injection site reaction	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Malaise	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Mucosal inflammation	2/51 (3.9%)		3/51 (5.9%)		3/18 (16.7%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		2/12 (16.7%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Oedema	1/51 (2%)		2/51 (3.9%)		2/18 (11.1%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Oedema peripheral	4/51 (7.8%)		4/51 (7.8%)		3/18 (16.7%)		3/18 (16.7%)		4/33 (12.1%)		3/21 (14.3%)		2/12 (16.7%)		3/15 (20%)		2/15 (13.3%)		1/7 (14.3%)
Pain	5/51 (9.8%)		4/51 (7.8%)		3/18 (16.7%)		2/18 (11.1%)		3/33 (9.1%)		0/21 (0%)		2/12 (16.7%)		3/15 (20%)		2/15 (13.3%)		0/7 (0%)
Peripheral swelling	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Pyrexia	18/51 (35.3%)		26/51 (51%)		4/18 (22.2%)		3/18 (16.7%)		18/33 (54.5%)		6/21 (28.6%)		4/12 (33.3%)		3/15 (20%)		8/15 (53.3%)		1/7 (14.3%)
Hepatobiliary disorders
Cholecystitis acute	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Immune system disorders
Anaphylactic reaction	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Drug hypersensitivity	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypersensitivity	2/51 (3.9%)		1/51 (2%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Hypogammaglobulinaemia	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Seasonal allergy	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Infections and infestations
Aspergillus infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Bacteraemia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Bronchitis	3/51 (5.9%)		2/51 (3.9%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Campylobacter infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Candida infection	1/51 (2%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cellulitis	1/51 (2%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Chronic sinusitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Clostridium difficile colitis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Clostridium difficile infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Conjunctivitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Diverticulitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Ear infection	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Fungal infection	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Fungal skin infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Gastroenteritis viral	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Gingivitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Herpes simplex	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		2/15 (13.3%)		0/15 (0%)		0/7 (0%)
Herpes virus infection	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Herpes zoster	3/51 (5.9%)		3/51 (5.9%)		0/18 (0%)		1/18 (5.6%)		2/33 (6.1%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Human herpesvirus 6 infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Infected cyst	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Mycobacterium avium complex infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Nasopharyngitis	5/51 (9.8%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		2/15 (13.3%)		0/15 (0%)		0/7 (0%)
Onychomycosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Oral candidiasis	5/51 (9.8%)		2/51 (3.9%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Oral herpes	3/51 (5.9%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Osteomyelitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Parvovirus infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Pneumocystis jirovecii pneumonia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Pneumonia	3/51 (5.9%)		2/51 (3.9%)		0/18 (0%)		2/18 (11.1%)		5/33 (15.2%)		1/21 (4.8%)		0/12 (0%)		2/15 (13.3%)		3/15 (20%)		0/7 (0%)
Pseudomonas infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Rhinitis	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Sinusitis	4/51 (7.8%)		6/51 (11.8%)		0/18 (0%)		1/18 (5.6%)		4/33 (12.1%)		4/21 (19%)		0/12 (0%)		2/15 (13.3%)		0/15 (0%)		0/7 (0%)
Sinusitis bacterial	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Skin infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Upper respiratory tract infection	10/51 (19.6%)		10/51 (19.6%)		1/18 (5.6%)		2/18 (11.1%)		3/33 (9.1%)		4/21 (19%)		1/12 (8.3%)		1/15 (6.7%)		3/15 (20%)		0/7 (0%)
Urinary tract infection	3/51 (5.9%)		3/51 (5.9%)		2/18 (11.1%)		1/18 (5.6%)		2/33 (6.1%)		3/21 (14.3%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Vulvovaginal mycotic infection	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Injury, poisoning and procedural complications
Contusion	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Fall	1/51 (2%)		0/51 (0%)		2/18 (11.1%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Humerus fracture	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Infusion related reaction	3/51 (5.9%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		5/33 (15.2%)		3/21 (14.3%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Procedural pain	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Pubis fracture	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rib fracture	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Skin abrasion	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Traumatic ulcer	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Investigations
Alanine aminotransferase increased	8/51 (15.7%)		17/51 (33.3%)		2/18 (11.1%)		5/18 (27.8%)		5/33 (15.2%)		2/21 (9.5%)		3/12 (25%)		1/15 (6.7%)		4/15 (26.7%)		5/7 (71.4%)
Aspartate aminotransferase increased	8/51 (15.7%)		14/51 (27.5%)		2/18 (11.1%)		5/18 (27.8%)		3/33 (9.1%)		2/21 (9.5%)		3/12 (25%)		1/15 (6.7%)		3/15 (20%)		5/7 (71.4%)
Blood albumin decreased	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood alkaline phosphatase increased	3/51 (5.9%)		6/51 (11.8%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Blood bilirubin increased	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		2/7 (28.6%)
Blood creatinine increased	1/51 (2%)		1/51 (2%)		4/18 (22.2%)		2/18 (11.1%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood glucose increased	1/51 (2%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood immunoglobulin A decreased	0/51 (0%)		3/51 (5.9%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood immunoglobulin G decreased	1/51 (2%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Blood immunoglobulin M decreased	0/51 (0%)		3/51 (5.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood lactate dehydrogenase increased	1/51 (2%)		4/51 (7.8%)		2/18 (11.1%)		2/18 (11.1%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		5/7 (71.4%)
Blood phosphorus decreased	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood pressure increased	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood sodium decreased	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood triglycerides increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		3/33 (9.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Blood urea increased	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Carbon dioxide decreased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Electrocardiogram QT prolonged	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Gamma-glutamyltransferase increased	4/51 (7.8%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Glucose tolerance increased	0/51 (0%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Liver function test abnormal	1/51 (2%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Lymphocyte count increased	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Neutrophil count decreased	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		3/33 (9.1%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Neutrophil count increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Protein total decreased	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Transaminases increased	1/51 (2%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Weight decreased	3/51 (5.9%)		6/51 (11.8%)		1/18 (5.6%)		2/18 (11.1%)		3/33 (9.1%)		1/21 (4.8%)		2/12 (16.7%)		1/15 (6.7%)		2/15 (13.3%)		0/7 (0%)
White blood cell count decreased	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
White blood cell count increased	0/51 (0%)		0/51 (0%)		0/18 (0%)		2/18 (11.1%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Metabolism and nutrition disorders
Decreased appetite	7/51 (13.7%)		7/51 (13.7%)		6/18 (33.3%)		3/18 (16.7%)		2/33 (6.1%)		5/21 (23.8%)		5/12 (41.7%)		2/15 (13.3%)		3/15 (20%)		0/7 (0%)
Dehydration	2/51 (3.9%)		3/51 (5.9%)		2/18 (11.1%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Diabetes mellitus	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Fluid overload	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Fluid retention	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Gout	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypercholesterolaemia	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyperglycaemia	3/51 (5.9%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		2/21 (9.5%)		2/12 (16.7%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Hyperkalaemia	1/51 (2%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyperlipidaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypertriglyceridaemia	0/51 (0%)		2/51 (3.9%)		2/18 (11.1%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hyperuricaemia	4/51 (7.8%)		0/51 (0%)		1/18 (5.6%)		2/18 (11.1%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		2/15 (13.3%)		1/15 (6.7%)		0/7 (0%)
Hypocalcaemia	0/51 (0%)		1/51 (2%)		2/18 (11.1%)		2/18 (11.1%)		0/33 (0%)		3/21 (14.3%)		2/12 (16.7%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Hypoglycaemia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypokalaemia	4/51 (7.8%)		5/51 (9.8%)		6/18 (33.3%)		4/18 (22.2%)		4/33 (12.1%)		2/21 (9.5%)		1/12 (8.3%)		2/15 (13.3%)		5/15 (33.3%)		1/7 (14.3%)
Hypomagnesaemia	1/51 (2%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		3/15 (20%)		0/7 (0%)
Hyponatraemia	1/51 (2%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		3/21 (14.3%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Hypophosphataemia	0/51 (0%)		0/51 (0%)		6/18 (33.3%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Metabolic acidosis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tumour lysis syndrome	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Type 2 diabetes mellitus	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Vitamin D deficiency	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	6/51 (11.8%)		4/51 (7.8%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Arthritis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Back pain	7/51 (13.7%)		5/51 (9.8%)		3/18 (16.7%)		0/18 (0%)		1/33 (3%)		3/21 (14.3%)		1/12 (8.3%)		1/15 (6.7%)		2/15 (13.3%)		0/7 (0%)
Bone pain	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Flank pain	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Groin pain	3/51 (5.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Muscle spasms	1/51 (2%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Muscular weakness	3/51 (5.9%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Musculoskeletal chest pain	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Musculoskeletal discomfort	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Musculoskeletal pain	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Myalgia	3/51 (5.9%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		2/21 (9.5%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		2/7 (28.6%)
Neck pain	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Pain in extremity	4/51 (7.8%)		2/51 (3.9%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		4/21 (19%)		1/12 (8.3%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Spinal column stenosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tendonitis	1/51 (2%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Malignant melanoma in situ	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Seborrhoeic keratosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Squamous cell carcinoma	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Nervous system disorders
Dizziness	8/51 (15.7%)		4/51 (7.8%)		1/18 (5.6%)		4/18 (22.2%)		3/33 (9.1%)		4/21 (19%)		2/12 (16.7%)		2/15 (13.3%)		2/15 (13.3%)		2/7 (28.6%)
Dysarthria	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Dysgeusia	4/51 (7.8%)		7/51 (13.7%)		2/18 (11.1%)		2/18 (11.1%)		1/33 (3%)		2/21 (9.5%)		2/12 (16.7%)		1/15 (6.7%)		3/15 (20%)		0/7 (0%)
Headache	12/51 (23.5%)		4/51 (7.8%)		3/18 (16.7%)		0/18 (0%)		3/33 (9.1%)		2/21 (9.5%)		2/12 (16.7%)		2/15 (13.3%)		1/15 (6.7%)		2/7 (28.6%)
Hyperaesthesia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypoaesthesia	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Lethargy	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Migraine	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Neuralgia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Neuropathy peripheral	2/51 (3.9%)		1/51 (2%)		0/18 (0%)		2/18 (11.1%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Normal pressure hydrocephalus	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Paraesthesia	2/51 (3.9%)		3/51 (5.9%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Peripheral sensory neuropathy	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Post herpetic neuralgia	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Presyncope	0/51 (0%)		0/51 (0%)		2/18 (11.1%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Seizure	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Trigeminal neuralgia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Psychiatric disorders
Agitation	0/51 (0%)		0/51 (0%)		2/18 (11.1%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Anxiety	3/51 (5.9%)		0/51 (0%)		3/18 (16.7%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		3/12 (25%)		3/15 (20%)		1/15 (6.7%)		0/7 (0%)
Confusional state	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Delirium	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Depression	2/51 (3.9%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hallucination	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Insomnia	7/51 (13.7%)		11/51 (21.6%)		3/18 (16.7%)		0/18 (0%)		6/33 (18.2%)		2/21 (9.5%)		1/12 (8.3%)		4/15 (26.7%)		3/15 (20%)		0/7 (0%)
Irritability	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Sleep disorder	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Stress	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Renal and urinary disorders
Acute kidney injury	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		2/33 (6.1%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dysuria	3/51 (5.9%)		1/51 (2%)		2/18 (11.1%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Haematuria	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Incontinence	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Nephrolithiasis	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Nocturia	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Pollakiuria	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Proteinuria	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Urinary incontinence	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Urinary retention	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Reproductive system and breast disorders
Genital swelling	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pelvic pain	1/51 (2%)		1/51 (2%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Vaginal haemorrhage	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Aspiration	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Asthma	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Asthma exercise induced	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Atelectasis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Bronchiectasis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Chylothorax	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Cough	18/51 (35.3%)		18/51 (35.3%)		7/18 (38.9%)		0/18 (0%)		9/33 (27.3%)		9/21 (42.9%)		6/12 (50%)		7/15 (46.7%)		4/15 (26.7%)		2/7 (28.6%)
Dysphonia	3/51 (5.9%)		5/51 (9.8%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Dyspnoea	7/51 (13.7%)		9/51 (17.6%)		3/18 (16.7%)		0/18 (0%)		5/33 (15.2%)		7/21 (33.3%)		2/12 (16.7%)		3/15 (20%)		3/15 (20%)		2/7 (28.6%)
Dyspnoea exertional	5/51 (9.8%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Epistaxis	0/51 (0%)		1/51 (2%)		7/18 (38.9%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		2/12 (16.7%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Haemoptysis	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hiccups	1/51 (2%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Hypoxia	0/51 (0%)		1/51 (2%)		3/18 (16.7%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		2/15 (13.3%)		1/15 (6.7%)		0/7 (0%)
Lung infiltration	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Nasal congestion	5/51 (9.8%)		4/51 (7.8%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Nasal dryness	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Oropharyngeal pain	5/51 (9.8%)		6/51 (11.8%)		2/18 (11.1%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		1/7 (14.3%)
Orthopnoea	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pleural effusion	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		2/18 (11.1%)		2/33 (6.1%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Productive cough	3/51 (5.9%)		5/51 (9.8%)		3/18 (16.7%)		0/18 (0%)		3/33 (9.1%)		3/21 (14.3%)		1/12 (8.3%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Pulmonary oedema	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Respiratory distress	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Respiratory failure	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rhinalgia	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Rhinorrhoea	4/51 (7.8%)		3/51 (5.9%)		3/18 (16.7%)		0/18 (0%)		0/33 (0%)		1/21 (4.8%)		3/12 (25%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Sinus congestion	1/51 (2%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Sinus disorder	0/51 (0%)		1/51 (2%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Sputum discoloured	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Tachypnoea	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Upper-airway cough syndrome	2/51 (3.9%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		2/33 (6.1%)		2/21 (9.5%)		0/12 (0%)		1/15 (6.7%)		1/15 (6.7%)		0/7 (0%)
Wheezing	0/51 (0%)		4/51 (7.8%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Actinic elastosis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Actinic keratosis	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dermatitis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Dermatitis allergic	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dermatitis contact	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Dry skin	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		2/18 (11.1%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Ecchymosis	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Eczema	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Erythema	1/51 (2%)		0/51 (0%)		1/18 (5.6%)		1/18 (5.6%)		1/33 (3%)		0/21 (0%)		2/12 (16.7%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Lentigo	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Night sweats	6/51 (11.8%)		7/51 (13.7%)		2/18 (11.1%)		2/18 (11.1%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		3/15 (20%)		0/15 (0%)		1/7 (14.3%)
Petechiae	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Photosensitivity reaction	0/51 (0%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Pruritus	5/51 (9.8%)		6/51 (11.8%)		4/18 (22.2%)		2/18 (11.1%)		5/33 (15.2%)		1/21 (4.8%)		0/12 (0%)		1/15 (6.7%)		2/15 (13.3%)		1/7 (14.3%)
Psoriasis	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash	11/51 (21.6%)		16/51 (31.4%)		5/18 (27.8%)		5/18 (27.8%)		13/33 (39.4%)		4/21 (19%)		2/12 (16.7%)		3/15 (20%)		5/15 (33.3%)		0/7 (0%)
Rash erythematous	2/51 (3.9%)		1/51 (2%)		0/18 (0%)		1/18 (5.6%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Rash generalised	2/51 (3.9%)		4/51 (7.8%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash macular	1/51 (2%)		1/51 (2%)		3/18 (16.7%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash maculo-papular	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Rash pruritic	0/51 (0%)		0/51 (0%)		0/18 (0%)		2/18 (11.1%)		0/33 (0%)		0/21 (0%)		2/12 (16.7%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Skin atrophy	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Skin disorder	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Skin hyperpigmentation	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Skin lesion	0/51 (0%)		0/51 (0%)		0/18 (0%)		1/18 (5.6%)		0/33 (0%)		1/21 (4.8%)		0/12 (0%)		2/15 (13.3%)		0/15 (0%)		0/7 (0%)
Skin ulcer	0/51 (0%)		0/51 (0%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		1/7 (14.3%)
Solar lentigo	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Swelling face	1/51 (2%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Urticaria	2/51 (3.9%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		1/21 (4.8%)		0/12 (0%)		0/15 (0%)		2/15 (13.3%)		0/7 (0%)
Surgical and medical procedures
Tooth extraction	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		0/33 (0%)		2/21 (9.5%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Vascular disorders
Deep vein thrombosis	0/51 (0%)		2/51 (3.9%)		2/18 (11.1%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Flushing	2/51 (3.9%)		3/51 (5.9%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		3/21 (14.3%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hot flush	0/51 (0%)		0/51 (0%)		0/18 (0%)		0/18 (0%)		1/33 (3%)		0/21 (0%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypertension	2/51 (3.9%)		2/51 (3.9%)		0/18 (0%)		1/18 (5.6%)		3/33 (9.1%)		2/21 (9.5%)		1/12 (8.3%)		0/15 (0%)		0/15 (0%)		0/7 (0%)
Hypotension	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		1/21 (4.8%)		2/12 (16.7%)		0/15 (0%)		1/15 (6.7%)		0/7 (0%)
Orthostatic hypotension	0/51 (0%)		2/51 (3.9%)		1/18 (5.6%)		0/18 (0%)		0/33 (0%)		0/21 (0%)		0/12 (0%)		1/15 (6.7%)		0/15 (0%)		0/7 (0%)
Phlebitis	0/51 (0%)		1/51 (2%)		0/18 (0%)		0/18 (0%)		2/33 (6.1%)		0/21 (0%)		0/12 (0%)		0/15 (0%)		0/15 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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