Study to Investigate Idelalisib in Combination With Chemo... | NCT01088048 | Trialant
NCT01088048
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Mar 18, 2021Actual
Enrollment
241Actual
Phase
Phase 1
Conditions
Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Interventions
Idelalisib
Rituximab
Bendamustine
Ofatumumab
Fludarabine
Everolimus
Bortezomib
Chlorambucil
Lenalidomide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01088048
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
101-07
Secondary IDs
Not provided
Brief Title
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
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
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 25, 2010Actual
Primary Completion Date
Apr 28, 2015Actual
Completion Date
Apr 28, 2015Actual
First Submitted Date
Mar 12, 2010
First Submission Date that Met QC Criteria
Mar 15, 2010
First Posted Date
Mar 17, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 11, 2021
Results First Submitted that Met QC Criteria
Feb 22, 2021
Results First Posted Date
Mar 18, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 22, 2021
Last Update Posted Date
Mar 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
Detailed Description
Not provided
Conditions Module
Conditions
Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Keywords
phosphatidylinositol 3-kinase
Ofatumumab
indolent non-Hodgkin lymphoma (iNHL)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
241Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Idelalisib + Rituximab
Experimental
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
Drug: Rituximab
Idelalisib + Rituximab + Bendamustine
Experimental
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
Drug: Rituximab
Drug: Bendamustine
Idelalisib + Bendamustine
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Idelalisib
Drug
Idelalisib tablet administered orally
Idelalisib + Bendamustine
Idelalisib + Bortezomib
Idelalisib + Chlorambucil
Idelalisib + Everolimus
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Duration of Exposure to IDELA
Duration of exposure to IDELA was summarized using descriptive statistics.
First dose date up to 12 months
Toxicity of Administration of IDELA
Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02
First dose date up to 5 years
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate
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
Up to 5 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clearview Cancer Institute
Huntsville
Alabama
35805
United States
UCLA
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Barrientos JC, Coutre SE, de Vos S, et al. Long-term follow-up of a Phase 1b trial of idelalisib in combination with chemoimmunotherapy in patients with relapsed/refractory chronic lymphocytic leukemia including patients with del17p/TP53 mutation. 51st Annual Meeting of the American Society of Clinical Oncology (ASCO). 29 May-02 June 2015; Chicago, IL, USA. [Poster 7011].
Result
Barrientos J, Coutre S, de Vos S, et al. Long-term follow-up of a Phase 1 study evaluating the selective PI3K-delta inhibitor idelalisib in combination with bendamustine (B), bendamustine/rituximab (BR), fludarabine (F), chlorambucil (Chl), Or chlorambucil/rituximab (ChlR) in patients with relapsed or refractory chronic lymphocytic leukemia. Society of Hematology (ASH) Annual Meeting. December 6-9, 2014; San Francisco, CA, USA. Poster 3343.
Result
de Vos S, Wagner-Johnston N, Coutre S, et al. Durable responses following treatment with the PI3K-delta inhibitor idelalisib in combination with rituximab, bendamustine, or both, in recurrent indolent non-Hodgkin lymphoma: Phase I/II results. Society of Hematology (ASH) Annual Meeting. December 6-9, 2014; San Francisco, CA, USA. Poster 3063.
Result
Barrientos J, Leonard J, Furman R, Flinn I, De Vos S, Coutre S, et al. Phase 1b study of idelalisib (GS-1101) plus chlorambucil ± rituximab in patients with relapsed and refractory chronic lymphocytic leukemia (CLL). European Hematology Association (EHA) 2013 Congress, 13-16 June 2013; Stockholm, Sweden. Abstract P100.
Result
Barrientos J, Sharman J, De Vos S, et al. GS-1101 (CAL-101), selective phosphatidylinositol 3-Kinase inhibitor, in combination with ofatumumab for treatment of relapsed/refractory chronic lymphocytic leukemia. European Hematology Association (EHA) 2012 Congress, 14-17 June 2012; Amsterdam, The Netherlands. Abstract 1062.
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).
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Idelalisib + Rituximab
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
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Idelalisib
Drug: Bendamustine
Idelalisib + Ofatumumab
Experimental
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
Drug: Ofatumumab
Idelalisib + Fludarabine
Experimental
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
Drug: Fludarabine
Idelalisib + Everolimus
Experimental
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
Drug: Everolimus
Idelalisib + Bortezomib
Experimental
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
Drug: Bortezomib
Idelalisib + Chlorambucil
Experimental
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
Drug: Chlorambucil
Idelalisib + Rituximab + Chlorambucil
Experimental
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
Drug: Rituximab
Drug: Chlorambucil
Idelalisib + Rituximab + Lenalidomide
Experimental
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
Drug: Rituximab
Drug: Lenalidomide
Idelalisib + Fludarabine
Idelalisib + Ofatumumab
Idelalisib + Rituximab
Idelalisib + Rituximab + Bendamustine
Idelalisib + Rituximab + Chlorambucil
Idelalisib + Rituximab + Lenalidomide
GS-1101
CAL-101
Zydelig®
Rituximab
Drug
Rituximab administered intravenously
Idelalisib + Rituximab
Idelalisib + Rituximab + Bendamustine
Idelalisib + Rituximab + Chlorambucil
Idelalisib + Rituximab + Lenalidomide
Rituxan
Bendamustine
Drug
Bendamustine administered intravenously
Idelalisib + Bendamustine
Idelalisib + Rituximab + Bendamustine
Treanda
Ofatumumab
Drug
Ofatumumab administered intravenously
Idelalisib + Ofatumumab
Arzerra
Fludarabine
Drug
Fludarabine administered orally
Idelalisib + Fludarabine
Fludara
Everolimus
Drug
Everolimus administered orally twice daily until disease progression
Idelalisib + Everolimus
Afinitor
RAD-001
Bortezomib
Drug
Bortezomib administered as a subcutaneous injection
Idelalisib + Bortezomib
Velcade
codenamed PS-341
Chlorambucil
Drug
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.
Idelalisib + Chlorambucil
Idelalisib + Rituximab + Chlorambucil
Leukeran
Lenalidomide
Drug
Lenalidomide administered orally
Idelalisib + Rituximab + Lenalidomide
Revlimid
Duration of Response
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.
Up to 5 years
Time to Response
Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.
Up to 5 years
Progression-free Survival
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
Up to 5 years
Overall Survival
Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.
Up to 5 years
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
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
Plasma Concentration of IDELA (Cohort 6)
Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24
Plasma Concentration of IDELA (Cohort 7)
Predose, 1.5 hours postdose at Weeks 0, 5 and 13
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
Predose, 1.5 hours postdose at Week 1 and predose at Week 5
Los Angeles
California
90024
United States
Stanford Cancer Center
Palo Alto
California
94304-5548
United States
Center for Cancer and Blood Disorders
Bethesda
Maryland
20817
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Long Island Jewish Medical Center
New Hyde Park
New York
11040
United States
Weill Medical College of Cornell
New York
New York
10021
United States
Willamette Valley Cancer Institute and Research Center
Springfield
Oregon
97477
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
MD Anderson Cancer
Houston
Texas
77030
United States
North Star Lodge Cancer Center
Yakima
Washington
98902
United States
Result
Coutre S, Leonard J, Furman R, et al. Combinations of the selective phosphatidylinositol 3 Kinase-delta (PI3Kd) inhibitor GS-1101 (CAL-101) with rituximab and/or bendamustine are tolerable and highly active in patients with relapsed or refractory chronic lymphocytic leukemia (CLL): results from a phase 1 study. American Society of Hematology (ASH) Annual Meeting. 8-11 December 2012; Atlanta, GA, USA. Abstract 642.
Result
de Vos S, Schreeder M, Finn I, et al. A phase 1 study of the selective phosphatidylinositol 3 Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). American Society of Hematology (ASH) 2011 Annual Meeting, 10-13 December 2011; San Diego, CA, USA. Abstract 2699.
Result
Flinn I, Schreeder M, Wagner-Johnson N, et al. A phase 1 study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-Kinase P110δ, in combination with rituximab and/or bendamustine in patients with relapsed or refractory B-cell malignancies. American Society of Hematology (ASH) 2010 Annual Meeting, 04-07 December 2010; Orlando, FL, USA. Blood (ASH Annual Meeting Abstracts) 2010 116: Abstract 2832.
Result
Flinn I, Schreeder M, Coutre S, et al. A phase 1 study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-Kinase P110δ, in combination with anti-CD20 monoclonal antibody therapy and/or bendamustine in patients with previously treated B-cell malignancies. 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). 04-08 June 2011; Chicago, IL, USA. [Poster 3064].
Result
Fowler N, de Vos S, Schreeder M, et al. Combinations of the phosphatidylinositol 3 Kinase delta (PI3Kd) inhibitor idelalisib (GS-1101) with rituximab and/or bendamustine are tolerable and highly active in previously treated, indolent non-Hodgkin lymphoma: results from a phase 1 study. American Society of Hematology (ASH) 2012.
Result
Furman R, Barrientos J, Sharman J, et al. A phase 1/2 study of the selective phosphatidylinositol 3-Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) with ofatumumab in patients with previously treated chronic lymphocytic leukemia (CLL). [Poster 6518] 2012 American Society of Clinical Oncology (ASCO) Annual Meeting; 01 05 June, 2012; Chicago, IL, USA. Gilead Sciences, Inc. [Poster 6518].
Result
Sharman J, de Vos S, Leonard J, et al. A phase 1 study of the selective phosphatidylinositol 3-Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia. American Society of Hematology (ASH) 2011 Annual Meeting, 10-13 December 2011; San Diego, CA, USA. Abstract 1787.
Result
Wagner-Johnston ND, De Vos S, Leonard J, Sharman JP, Schreeder MT, Boccia RV, et al. Preliminary results of PI3Kδ inhibitor idelalisib (GS-1101) treatment in combination with everolimus, bortezomib, or bendamustine/rituximab in patients with previously treated mantle cell lymphoma (MCL) [Abstract 8501]. J Clin Oncol (ASCO Annual Meeting Abstracts) 2013;31 (suppl).
Coutre SE, Flinn IW, de Vos S, Barrientos JC, Schreeder MT, Wagner-Johnson ND, Sharman JP, Boyd TE, Fowler N, Dreiling L, Kim Y, Mitra S, Rai K, Leonard JP, Furman RR. Idelalisib in Combination With Rituximab or Bendamustine or Both in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia. Hemasphere. 2018 Apr 25;2(3):e39. doi: 10.1097/HS9.0000000000000039. eCollection 2018 Jun.
de Vos S, Wagner-Johnston ND, Coutre SE, Flinn IW, Schreeder MT, Fowler NH, Sharman JP, Boccia RV, Barrientos JC, Rai KR, Boyd TE, Furman RR, Kim Y, Godfrey WR, Leonard JP. Combinations of idelalisib with rituximab and/or bendamustine in patients with recurrent indolent non-Hodgkin lymphoma. Blood Adv. 2016 Nov 30;1(2):122-131. doi: 10.1182/bloodadvances.2016000976. eCollection 2016 Dec 13.
Stevenson FK, Krysov S, Davies AJ, Steele AJ, Packham G. B-cell receptor signaling in chronic lymphocytic leukemia. Blood. 2011 Oct 20;118(16):4313-20. doi: 10.1182/blood-2011-06-338855. Epub 2011 Aug 3.
FG001
Idelalisib + Bendamustine
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
FG002
Idelalisib + Everolimus
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
FG003
Idelalisib + Bortezomib
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
FG004
Idelalisib + Rituximab + Bendamustine
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
FG005
Idelalisib + Ofatumumab
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))
FG006
Idelalisib + Fludarabine
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
FG007
Idelalisib + Chlorambucil
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
FG008
Idelalisib + Rituximab + Chlorambucil
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
FG009
Idelalisib + Rituximab + Lenalidomide
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
FG00051 subjects
FG00151 subjects
FG00218 subjects
FG00318 subjects
FG00433 subjects
FG00521 subjects
FG00612 subjects
FG00715 subjects
FG00815 subjects
FG0097 subjects
Participants With CLL
FG00019 subjects
FG00118 subjects
FG0020 subjects
FG0030 subjects
FG00415 subjects
FG00521 subjects
FG00612 subjects
FG00715 subjects
FG00814 subjects
FG0091 subjects
Participants With Indolent NHL
FG00032 subjects
FG00133 subjects
FG0020 subjects
FG0030 subjects
FG00414 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0096 subjects
Participants With MCL
FG0000 subjects
FG0010 subjects
FG00218 subjects
FG00318 subjects
FG0044 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00029 subjects
FG00124 subjects
FG0024 subjects
FG0034 subjects
FG00416 subjects
FG00510 subjects
FG0066 subjects
FG00710 subjects
FG0088 subjects
FG0093 subjects
NOT COMPLETED
FG00022 subjects
FG00127 subjects
FG00214 subjects
FG00314 subjects
FG00417 subjects
FG00511 subjects
FG0066 subjects
FG0075 subjects
FG0087 subjects
FG0094 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0019 subjects
FG0027 subjects
FG0035 subjects
FG0046 subjects
FG0053 subjects
FG0063 subjects
FG0070 subjects
FG0082 subjects
FG0092 subjects
Withdrew Consent
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Concomitant Medication Prohibited
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator Request
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient Non-compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0007 subjects
FG0014 subjects
FG0023 subjects
FG0035 subjects
FG004
Death
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0033 subjects
FG004
Other
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
The intent-to-treat (ITT) analysis set included participants who received at least 1 dose of study drug (Idelalisib or combination drugs). Per prespecified analysis, participants were grouped by disease (CLL, iNHL, MCL) and by treatment regimen (cohort).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Idelalisib + Rituximab
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
BG001
Idelalisib + Bendamustine
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
BG002
Idelalisib + Everolimus
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
BG003
Idelalisib + Bortezomib
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
BG004
Idelalisib + Rituximab + Bendamustine
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
BG005
Idelalisib + Ofatumumab
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))
BG006
Idelalisib + Fludarabine
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
BG007
Idelalisib + Chlorambucil
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
BG008
Idelalisib + Rituximab + Chlorambucil
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
BG009
Idelalisib + Rituximab + Lenalidomide
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
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00151
BG00218
BG00318
BG00433
BG00521
BG00612
BG00715
BG00815
BG0097
BG010241
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065± 10.1
BG00161± 11.2
BG00269± 7.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG00121
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
White/Caucasian
BG00042
BG00145
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Duration of Exposure to IDELA
Duration of exposure to IDELA was summarized using descriptive statistics.
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).
Posted
Mean
Standard Deviation
months
First dose date up to 12 months
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00051
OG00151
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.1± 3.74
OG0017.6± 3.96
OG0024.2± 3.92
OG003
Primary
Toxicity of Administration of IDELA
Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02
Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).
Posted
Number
percentage of participants
First dose date up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Overall Response Rate
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
Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Duration of Response
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.
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).
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Time to Response
Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.
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).
Posted
Median
Inter-Quartile Range
months
Up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Progression-free Survival
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
Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Overall Survival
Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.
Participants in the ITT analysis set were analyzed. Per prespecified analysis, participants for this outcome measure were grouped by disease and treatment regimen (cohort).
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
Idelalisib + Rituximab
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
OG001
Idelalisib + Bendamustine
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
Secondary
Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5)
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.
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
Idelalisib 100 mg (Cohort 1)
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
OG001
Idelalisib 150 mg (Cohorts 2 and 3)
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
Secondary
Plasma Concentration of IDELA (Cohort 4)
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.
Posted
Mean
Standard Deviation
ng/mL
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
ID
Title
Description
OG000
Idelalisib 150 mg (Cohort 4)
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
Units
Counts
Participants
OG000
Secondary
Plasma Concentration of IDELA (Cohort 6)
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.
Posted
Mean
Standard Deviation
ng/mL
Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24
ID
Title
Description
OG000
Idelalisib 150 mg (Cohort 6)
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
Units
Counts
Participants
OG000
Secondary
Plasma Concentration of IDELA (Cohort 7)
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.
Posted
Mean
Standard Deviation
ng/mL
Predose, 1.5 hours postdose at Weeks 0, 5 and 13
ID
Title
Description
OG000
Idelalisib 150 mg (Cohort 7)
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
Secondary
Sub-study: Plasma Concentration of IDELA (Cohorts 1-4)
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.
Posted
Mean
Standard Deviation
ng/mL
pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose
ID
Title
Description
OG000
Idelalisib 100 mg (Cohort 1a, 1b)
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
Secondary
Plasma Concentration of Bendamustine
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.
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)
Secondary
Plasma Concentration of Everolimus
Participants in the PK analysis set with available data were analyzed. Data were summarized for participants in Cohort 5a who received everolimus.
Posted
Mean
Standard Deviation
ng/mL
Predose, 1.5 hours postdose at Weeks 0 and 4
ID
Title
Description
OG000
Everolimus (Cohort 5a)
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
Units
Counts
Participants
OG000
Secondary
Plasma Concentration of Lenalidomide
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.
Posted
Mean
Standard Deviation
ng/mL
Predose, 1.5 hours postdose at Week 1 and predose at Week 5
ID
Title
Description
OG000
Lenalidomide (Cohort 7a, 7b, 7c)
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
Time Frame
First dose date up to 5 years
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).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Idelalisib + Rituximab
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
1
51
20
51
51
51
EG001
Idelalisib + Bendamustine
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
6
51
37
51
51
51
EG002
Idelalisib + Everolimus
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
4
18
14
18
18
18
EG003
Idelalisib + Bortezomib
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
3
18
6
18
15
18
EG004
Idelalisib + Rituximab + Bendamustine
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
1
33
17
33
33
33
EG005
Idelalisib + Ofatumumab
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))
4
21
12
21
21
21
EG006
Idelalisib + Fludarabine
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
2
12
9
12
12
12
EG007
Idelalisib + Chlorambucil
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
0
15
9
15
15
15
EG008
Idelalisib + Rituximab + Chlorambucil
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
3
15
8
15
15
15
EG009
Idelalisib + Rituximab + Lenalidomide
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
2
7
5
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG0030 affected18 at risk
EG0040 affected33 at risk
EG0050 affected21 at risk
EG0061 affected12 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected7 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Coombs positive haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0015 affected51 at risk
EG0022 affected18 at risk
EG003
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Endocrine disorder
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Uveitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Generalised oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Multi-organ failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG00110 affected51 at risk
EG0021 affected18 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Candida infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cytomegalovirus gastrointestinal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes zoster disseminated
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes zoster pharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Human herpesvirus 6 infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Listeria sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Listeriosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Lung infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG00110 affected51 at risk
EG0022 affected18 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0014 affected51 at risk
EG0020 affected18 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Transaminases increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0023 affected18 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Obstructive uropathy
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchial secretion retention
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected51 at risk
EG00113 affected51 at risk
EG0025 affected18 at risk
EG0035 affected18 at risk
EG0044 affected33 at risk
EG0053 affected21 at risk
EG0063 affected12 at risk
EG0073 affected15 at risk
EG0084 affected15 at risk
EG0090 affected7 at risk
Coombs positive haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected51 at risk
EG0021 affected18 at risk
EG003
Hypoglobulinaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0016 affected51 at risk
EG0022 affected18 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG00015 affected51 at risk
EG00127 affected51 at risk
EG0027 affected18 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG00114 affected51 at risk
EG00211 affected18 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0023 affected18 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected51 at risk
EG0021 affected18 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Cataract
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Dry eye
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0022 affected18 at risk
EG003
Eye irritation
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Eyelid thickening
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Vision blurred
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Visual impairment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected51 at risk
EG0022 affected18 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected51 at risk
EG0016 affected51 at risk
EG0021 affected18 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG00111 affected51 at risk
EG0022 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected51 at risk
EG00114 affected51 at risk
EG0029 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0019 affected51 at risk
EG0021 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0015 affected51 at risk
EG0020 affected18 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00017 affected51 at risk
EG00119 affected51 at risk
EG0022 affected18 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0014 affected51 at risk
EG0022 affected18 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0016 affected51 at risk
EG0022 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected51 at risk
EG0023 affected18 at risk
EG003
Catheter site pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Chest discomfort
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Chills
General disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected51 at risk
EG00111 affected51 at risk
EG0024 affected18 at risk
EG003
Face oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG00018 affected51 at risk
EG00124 affected51 at risk
EG0025 affected18 at risk
EG003
Gait disturbance
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Inflammation
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Infusion site pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Injection site discomfort
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Injection site erythema
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Injection site reaction
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Malaise
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected51 at risk
EG0023 affected18 at risk
EG003
Oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0022 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0014 affected51 at risk
EG0023 affected18 at risk
EG003
Pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected51 at risk
EG0023 affected18 at risk
EG003
Peripheral swelling
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG00018 affected51 at risk
EG00126 affected51 at risk
EG0024 affected18 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Candida infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Ear infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Human herpesvirus 6 infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Infected cyst
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Parvovirus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0016 affected51 at risk
EG0020 affected18 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected51 at risk
EG00110 affected51 at risk
EG0021 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0013 affected51 at risk
EG0022 affected18 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0022 affected18 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Traumatic ulcer
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0008 affected51 at risk
EG00117 affected51 at risk
EG0022 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0008 affected51 at risk
EG00114 affected51 at risk
EG0022 affected18 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0016 affected51 at risk
EG0020 affected18 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0024 affected18 at risk
EG003
Blood glucose increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Blood immunoglobulin A decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected51 at risk
EG0021 affected18 at risk
EG003
Blood immunoglobulin G decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Blood immunoglobulin M decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected51 at risk
EG0021 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0014 affected51 at risk
EG0022 affected18 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Blood pressure increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Blood urea increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Carbon dioxide decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Glucose tolerance increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Protein total decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Transaminases increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0016 affected51 at risk
EG0021 affected18 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
White blood cell count increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected51 at risk
EG0017 affected51 at risk
EG0026 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected51 at risk
EG0022 affected18 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0022 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0022 affected18 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0015 affected51 at risk
EG0026 affected18 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0026 affected18 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected51 at risk
EG0014 affected51 at risk
EG0020 affected18 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected51 at risk
EG0015 affected51 at risk
EG0023 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected51 at risk
EG0014 affected51 at risk
EG0021 affected18 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0017 affected51 at risk
EG0022 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00012 affected51 at risk
EG0014 affected51 at risk
EG0023 affected18 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Migraine
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0022 affected18 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0022 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected51 at risk
EG0023 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected51 at risk
EG00111 affected51 at risk
EG0023 affected18 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Stress
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected51 at risk
EG0022 affected18 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Genital swelling
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Asthma exercise induced
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00018 affected51 at risk
EG00118 affected51 at risk
EG0027 affected18 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0015 affected51 at risk
EG0020 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected51 at risk
EG0019 affected51 at risk
EG0023 affected18 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0027 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0023 affected18 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected51 at risk
EG0020 affected18 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0016 affected51 at risk
EG0022 affected18 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected51 at risk
EG0015 affected51 at risk
EG0023 affected18 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected51 at risk
EG0013 affected51 at risk
EG0023 affected18 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0021 affected18 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0014 affected51 at risk
EG0021 affected18 at risk
EG003
Actinic elastosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Lentigo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected51 at risk
EG0017 affected51 at risk
EG0022 affected18 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected51 at risk
EG0016 affected51 at risk
EG0024 affected18 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected51 at risk
EG00116 affected51 at risk
EG0025 affected18 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0014 affected51 at risk
EG0020 affected18 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0023 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected18 at risk
EG003
Solar lentigo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0022 affected18 at risk
EG003
Flushing
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected51 at risk
EG0020 affected18 at risk
EG003
Hot flush
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected51 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected51 at risk
EG0021 affected18 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
Point of Contact
Title
Organization
Phone
Extension
Email
Gilead Clinical Study Information Center
Gilead Sciences
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
ID
Term
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D020522
Lymphoma, Mantle-Cell
Ancestor Terms
ID
Term
D015448
Leukemia, B-Cell
D007945
Leukemia, Lymphoid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D008228
Lymphoma, Non-Hodgkin
D008223
Lymphoma
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C552946
idelalisib
D000069283
Rituximab
D000069461
Bendamustine Hydrochloride
C527517
ofatumumab
C024352
fludarabine
C042382
fludarabine phosphate
D000068338
Everolimus
D000069286
Bortezomib
D002699
Chlorambucil
D000077269
Lenalidomide
Ancestor Terms
ID
Term
D058846
Antibodies, Monoclonal, Murine-Derived
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D009588
Nitrogen Mustard Compounds
D009150
Mustard Compounds
D006846
Hydrocarbons, Halogenated
D006838
Hydrocarbons
D001562
Benzimidazoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D020123
Sirolimus
D018942
Macrolides
D007783
Lactones
D001897
Boronic Acids
D000148
Acids, Noncarboxylic
D000143
Acids
D007287
Inorganic Chemicals
D001896
Boron Compounds
D011719
Pyrazines
D006573
Heterocyclic Compounds, 1-Ring
D010797
Phthalimides
D010795
Phthalic Acids
D000146
Acids, Carbocyclic
D010881
Piperidones
D010880
Piperidines
D054833
Isoindoles
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
3 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
3 subjects
FG0053 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
72
± 6.0
BG00460± 8.3
BG00566± 9.7
BG00669± 7.1
BG00763± 7.8
BG00868± 10.0
BG00961± 8.3
BG01064± 9.9
7
BG0033
BG00412
BG0056
BG0064
BG0071
BG0084
BG0092
BG01076
Male
BG00035
BG00130
BG00211
BG00315
BG00421
BG00515
BG0068
BG00714
BG00811
BG0095
BG010165
16
BG00314
BG00429
BG00520
BG0068
BG00714
BG00815
BG0096
BG010209
Black or African American
BG0002
BG0013
BG0020
BG0030
BG0041
BG0050
BG0061
BG0071
BG0080
BG0091
BG0109
Asian
BG0005
BG0011
BG0021
BG0032
BG0041
BG0050
BG0061
BG0070
BG0080
BG0090
BG01011
Other
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
Not Reported
BG0002
BG0012
BG0021
BG0032
BG0042
BG0050
BG0062
BG0070
BG0080
BG0090
BG01011
0
BG0031
BG0040
BG0050
BG0060
BG0071
BG0080
BG0090
BG0104
Not Hispanic or Latino
BG00051
BG00149
BG00218
BG00317
BG00431
BG00521
BG00611
BG00714
BG00815
BG0097
BG010234
Missing
BG0000
BG0010
BG0020
BG0030
BG0042
BG0050
BG0061
BG0070
BG0080
BG0090
BG0103
18
OG00433
OG00521
OG00612
OG00715
OG00815
OG0097
5.1
± 3.90
OG0048.0± 4.16
OG0058.3± 4.03
OG0068.9± 3.57
OG0078.8± 3.76
OG0088.7± 3.01
OG0097.7± 4.78
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00051
OG00151
OG00218
OG00318
OG00433
OG00521
OG00612
OG00715
OG00815
OG0097
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG00383.33
OG004100.0
OG005100.0
OG006100.0
OG007100.0
OG008100.0
OG009100.0
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00051
OG00151
OG00218
OG00318
OG00433
OG00521
OG00612
OG00715
OG00815
OG0097
Title
Denominators
Categories
Title
Measurements
OG00078.4(64.7 to 88.7)
OG00184.3(71.4 to 93.0)
OG00244.4(21.5 to 69.2)
OG00361.1(35.7 to 82.7)
OG00481.8(64.5 to 93.0)
OG00571.4(47.8 to 88.7)
OG00691.7(61.5 to 99.8)
OG00766.7(38.4 to 88.2)
OG00893.3(68.1 to 99.8)
OG00971.4(29.0 to 96.3)
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00040
OG00143
OG0028
OG00311
OG00427
OG00515
OG00611
OG00710
OG00814
OG0095
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG001NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG0025.6(1.1 to NA)NA = Not Reached; too few events to estimate the upper limit of the confidence interval
OG0039.3(4.9 to 9.3)
OG004NA(9.9 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG005NA(9.4 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG006NA(3.5 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG007NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG008NA(4.4 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG009NA(1.3 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00040
OG00143
OG0028
OG00311
OG00427
OG00515
OG00611
OG00710
OG00814
OG0095
Title
Denominators
Categories
Title
Measurements
OG0001.9(1.9 to 2.1)
OG0011.9(1.9 to 2.0)
OG0021.9(1.9 to 2.6)
OG0031.9(1.9 to 1.9)
OG0041.9(1.9 to 2.0)
OG0051.9(1.9 to 2.3)
OG0061.9(1.8 to 1.9)
OG0071.9(1.9 to 1.9)
OG0081.9(1.9 to 3.7)
OG0093.0(2.6 to 4.0)
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00051
OG00151
OG00218
OG00318
OG00433
OG00521
OG00612
OG00715
OG00815
OG0097
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG001NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG0024.3(1.6 to 11.1)
OG0038.1(1.8 to NA)NA = Not Reached; too few events to estimate the upper limit of the confidence interval
OG004NA(11.7 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG005NA(8.7 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG006NA(5.4 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG007NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG008NA(6.7 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG009NA(5.5 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG002
Idelalisib + Everolimus
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
OG003
Idelalisib + Bortezomib
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
OG004
Idelalisib + Rituximab + Bendamustine
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
OG005
Idelalisib + Ofatumumab
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))
OG006
Idelalisib + Fludarabine
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
OG007
Idelalisib + Chlorambucil
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
OG008
Idelalisib + Rituximab + Chlorambucil
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
OG009
Idelalisib + Rituximab + Lenalidomide
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
Units
Counts
Participants
OG00051
OG00151
OG00218
OG00318
OG00433
OG00521
OG00612
OG00715
OG00815
OG0097
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG001NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG002NA(3.4 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG003NA(5.2 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG004NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG005NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG006NA(6.3 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG007NA(NA to NA)NA = Not Reached; too few events to estimate the median and the lower and upper limits of the confidence interval
OG008NA(6.7 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG009NA(5.5 to NA)NA = Not Reached; too few events to estimate the median and the upper limit of the confidence interval
OG002
Idelalisib 150 mg (Cohort 5)
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
Units
Counts
Participants
OG00024
OG001123
OG00245
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG00024
ParticipantsOG001111
ParticipantsOG00236
Title
Measurements
OG0000.4± 2.16
OG00168.8± 396.94
OG0020.0± 0.0
0.5 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00122
ParticipantsOG0021
Title
Measurements
OG000
1.0 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00122
ParticipantsOG0021
Title
Measurements
OG000
1.5 hr post-dose (Week 0)
ParticipantsOG00024
ParticipantsOG001112
ParticipantsOG00236
Title
Measurements
OG000
2.0 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00121
ParticipantsOG0021
Title
Measurements
OG000
3.0 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00122
ParticipantsOG0021
Title
Measurements
OG000
4.0 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00122
ParticipantsOG0021
Title
Measurements
OG000
6.0 hr post-dose (Week 0)
ParticipantsOG0007
ParticipantsOG00121
ParticipantsOG0021
Title
Measurements
OG000
Pre-dose (Week 4)
ParticipantsOG00022
ParticipantsOG00199
ParticipantsOG00229
Title
Measurements
OG000
1.5 hr post-dose (Week 4)
ParticipantsOG00020
ParticipantsOG00195
ParticipantsOG00224
Title
Measurements
OG000
Pre-dose (Week 12)
ParticipantsOG00019
ParticipantsOG00178
ParticipantsOG00216
Title
Measurements
OG000
1.5 hr post-dose (Week 12)
ParticipantsOG00017
ParticipantsOG00177
ParticipantsOG00212
Title
Measurements
OG000
Pre-dose (Week 24)
ParticipantsOG00011
ParticipantsOG00176
ParticipantsOG0027
Title
Measurements
OG000
1.5 hr post-dose (Week 24)
ParticipantsOG0008
ParticipantsOG00172
ParticipantsOG0025
Title
Measurements
OG000
18
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG0003
Title
Measurements
OG0000.0± 0.0
Pre-dose (Week 4)
ParticipantsOG00013
Title
Measurements
OG0000.0± 0.0
0.5 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG0001119.5± 1513.99
1.0 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG000994.5± 601.75
1.5 hr post-dose (Week 4)
ParticipantsOG00012
Title
Measurements
OG0001758.2± 1414.07
2.0 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG000737.0± 108.89
3.0 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG000605.0± 18.38
4.0 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG000547.0± 158.39
6.0 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG000524.0± 404.47
Pre-dose (Week 12)
ParticipantsOG00013
Title
Measurements
OG000401.9± 344.93
1.5 hr post-dose (Week 12)
ParticipantsOG00011
Title
Measurements
OG0002018.2± 1703.98
Pre-dose (Week 24)
ParticipantsOG00012
Title
Measurements
OG000752.5± 967.91
1.5 hr post-dose (Week 24)
ParticipantsOG00010
Title
Measurements
OG0002251.1± 1744.44
30
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG00030
Title
Measurements
OG0000.0± 0.0
1.5 hr post-dose (Week 0)
ParticipantsOG00027
Title
Measurements
OG0001930.7± 1220.87
Pre-dose (Week 4)
ParticipantsOG00024
Title
Measurements
OG000530.8± 563.59
1.5 hr post-dose (Week 4)
ParticipantsOG00022
Title
Measurements
OG0001869.8± 1001.39
Pre-dose (Week 12)
ParticipantsOG00025
Title
Measurements
OG000677.9± 940.94
1.5 hr post-dose (Week 12)
ParticipantsOG00018
Title
Measurements
OG0001733.0± 941.94
Pre-dose (Week 24)
ParticipantsOG00021
Title
Measurements
OG000346.8± 377.84
1.5 hr post-dose (Week 24)
ParticipantsOG00019
Title
Measurements
OG0001710.7± 1235.08
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG0007
Title
Measurements
OG000NA± NAValues were below the limit of quantitation
1.5 hr post-dose (Week 0)
ParticipantsOG0007
Title
Measurements
OG0001603.1± 1196.78
Pre-dose (Week 5)
ParticipantsOG0006
Title
Measurements
OG00020.7± 50.13
1.5 hr post-dose (Week 5)
ParticipantsOG0006
Title
Measurements
OG0001621.3± 663.80
Pre-dose (Week 13)
ParticipantsOG0004
Title
Measurements
OG000354.8± 278.62
1.5 hr post-dose (Week 13)
ParticipantsOG0003
Title
Measurements
OG000592.7± 597.52
Units
Counts
Participants
OG0007
OG00124
Title
Denominators
Categories
Pre-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG0001.5± 4.01
OG0010.0± 0.0
0.5 hr post-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG000437.6± 380.08
OG001
1.0 hr post-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG0001022.4± 652.92
OG001
1.5 hr post-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG0001264.7± 868.41
OG001
2.0 hr post-dose
ParticipantsOG0007
ParticipantsOG00123
Title
Measurements
OG0001282.7± 789.24
OG001
3.0 hr post-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG0001001.0± 633.99
OG001
4.0 hr post-dose
ParticipantsOG0007
ParticipantsOG00124
Title
Measurements
OG000788.4± 629.67
OG001
6.0 hr post-dose
ParticipantsOG0007
ParticipantsOG00123
Title
Measurements
OG000523.7± 418.80
OG001
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG00019
Title
Measurements
OG000NA± NAValues were below the limit of quantitation
0.25 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG0003484.1± 2617.17
0.5 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG0004694.7± 3570.78
0.75 hr post-dose (Week 0)
ParticipantsOG00019
Title
Measurements
OG0003433.2± 2991.15
1.0 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG0002847.2± 2462.90
1.25 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG0001916.4± 1551.50
1.5 hr post-dose (Week 0)
ParticipantsOG00017
Title
Measurements
OG0001211.2± 1093.74
2.0 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG000514.0± 489.76
3.0 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG000463.4± 1529.30
4.0 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG00078.5± 238.30
5.0 hr post-dose (Week 0)
ParticipantsOG00018
Title
Measurements
OG00015.3± 36.79
6.0 hr post-dose (Week 0)
ParticipantsOG00016
Title
Measurements
OG0004.4± 6.58
6
Title
Denominators
Categories
Pre-dose (Week 0)
ParticipantsOG0004
Title
Measurements
OG000NA± NAValues were below the limit of quantitation
1.5 hr post-dose (Week 0)
ParticipantsOG0006
Title
Measurements
OG00093.0± 63.50
Pre-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG0003.0± 3.79
1.5 hr post-dose (Week 4)
ParticipantsOG0002
Title
Measurements
OG00056.3± 67.48
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Pre-dose (Week 1)
ParticipantsOG0007
Title
Measurements
OG000NA± NAValues were below the limit of quantitation
1.5 hr post-dose (Week 1)
ParticipantsOG0006
Title
Measurements
OG00051.6± 31.77
Pre-dose (Week 5)
ParticipantsOG0002
Title
Measurements
OG000NA± NAValues were below the limit of quantitation