Myelofibrosis
Conditions
Brief summary
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease. This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).
Interventions
DRUGIdelalisib
Idelalisib tablets administered orally for 24 weeks
DRUGRuxolitinib
Ruxolitinib will be administered per standard of care according to package insert
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry * Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or intermediate risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available * Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet 2013 Revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and relapsed disease, with modifications for progressive disease complete remission (CR), partial remission (PR), or clinical improvement (CI) * European Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Required screening laboratory values as described in the protocol * Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP) * Able to understand and willing to sign the informed consent form Key
Exclusion criteria
* Individuals on a stable ruxolitinib dose of 5 mg once daily * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver * Ongoing drug-induced pneumonitis * Ongoing inflammatory bowel disease * Ongoing alcohol or drug addiction * Symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or unstable cardiac arrhythmia requiring medication * Known hypersensitivity to the study investigational medicinal product (IMP), the metabolites, or formulation excipients * Unwilling or unable to take oral medication * Unresolved non-hematologic toxicities from prior therapies that are \> Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia \[Grade 1 or 2 permitted\]) * Pregnant or lactating females * Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | — |
| Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | — |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | First dose date up to 28 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. |
| Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure | First dose date up to the last dose date (maximum:15.1 months) plus 30 days | — |
| Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Predose Week 2, 1.5 hour Week 2, and Predose Week 3 | — |
| Rate of Overall Response | Start of treatment to end of treatment ( up to 15.1 months) | Rate of overall response as defined by 2013 Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria. |
| Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure | First dose date up to the last dose date (maximum:15.1 months) plus 30 days | — |
| Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure | First dose date up to the last dose date (maximum:15.1 months) plus 30 days | — |
| Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | First dose date up to the last dose date (maximum:15.1 months) plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States. The first participant was screened on 05 June 2015. The last study visit occurred on 20 November 2017.
Pre-assignment details
12 participants were screened. Participants were enrolled in Cohorts A and B. After the fourth participant in Cohort B was enrolled, the study was terminated. No additional participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A, Idelalisib + Ruxolitinib Idelalisib tablet 50 mg orally once daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post- PV myelofibrosis, or post-ET MF. | 6 |
| Cohort B, Idelalisib + Ruxolitinib Idelalisib tablet 50 mg orally twice daily for 24 weeks in participants receiving ruxolitinib as therapy for PMF, post-PV myelofibrosis or post-ET MF. | 4 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Investigator Discretion | 1 | 2 |
| Overall Study | Progressive Disease | 3 | 1 |
| Overall Study | Study Terminated By Sponsor | 0 | 1 |
| Overall Study | Withdrawal by Participant | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort B, Idelalisib + Ruxolitinib | Total | Cohort A, Idelalisib + Ruxolitinib |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 6.1 | 65 years STANDARD_DEVIATION 9.1 | 62 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized Others | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 6 / 6 | 4 / 4 |
| serious Total, serious adverse events | 3 / 6 | 0 / 4 |
Outcome results
Primary
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure
Time frame: First dose date up to 28 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure | 33.3 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Adverse Events Related to Idelalisib Within 28 Days of Idelalisib Exposure | 0 Percentage of participants |
Primary
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure
Time frame: First dose date up to 28 days
Population: Full Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure | 100.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events Within 28 Days of Idelalisib Exposure | 75.0 Percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Time frame: First dose date up to 28 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 2) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 2) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 1) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 2) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 1) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 4) | 16.7 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 1) | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 3) | 0 Percentage of participants |
Primary
Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure
Time frame: First dose date up to 28 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure | 0.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Within 28 Days of Idelalisib Exposure | 0.0 Percentage of participants |
Secondary
Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Time frame: First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 3) | 50.0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 2) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 1) | 50.0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Transferase (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 3) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 4) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 2) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 1) | 50.0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 1) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 3) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 1) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 2) | 16.7 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 1) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 4) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 1) | 33.3 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 2) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 3) | 0 Percentage of participants |
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 4) | 16.7 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 4) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 1) | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Transferase (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 4) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoglycemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypomagnesemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 3) | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 1) | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 3) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase Increased (Grade 3) | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 1) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperkalemia (Grade 4) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Platelet count decreased (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 2) | 0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 1) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 2) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 3) | 25.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Abnormal Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 2) | 0 Percentage of participants |
Secondary
Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure
Time frame: First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure | 50.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Adverse Events Related to Idelalisib Beyond 28 Days of Idelalisib Exposure | 25.0 Percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure
Time frame: First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure | 100.0 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Experiencing Treatment Emergent Adverse Events Beyond 28 Days of Idelalisib Exposure | 100.0 Percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure
Time frame: First dose date up to the last dose date (maximum:15.1 months) plus 30 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure | 16.7 Percentage of participants |
| Cohort B, Idelalisib + Ruxolitinib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to an Adverse Event Beyond 28 Days of Exposure | 25.0 Percentage of participants |
Secondary
Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite)
Time frame: Predose Week 2, 1.5 hour Week 2, and Predose Week 3
Population: The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose value reported by the PK laboratory.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: Predose Week 2 | 396.6 ng/mL | Standard Deviation 406.95 |
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: 1.5 hour Postdose Week 2 | 1051.4 ng/mL | Standard Deviation 692.36 |
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: Predose Week 3 | 227.9 ng/mL | Standard Deviation 212.1 |
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: Predose Week 2 | 9.95 ng/mL | Standard Deviation 6.534 |
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: 1.5 hour Postdose Week 2 | 835.00 ng/mL | Standard Deviation 487.102 |
| Cohort A, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: Predose Week 3 | 6.67 ng/mL | Standard Deviation 1.77 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: 1.5 hour Postdose Week 2 | 760.25 ng/mL | Standard Deviation 438.644 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: Predose Week 2 | 1156.8 ng/mL | Standard Deviation 1252.69 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: Predose Week 2 | 106.83 ng/mL | Standard Deviation 107.549 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: 1.5 hour Postdose Week 2 | 1405.5 ng/mL | Standard Deviation 1228.45 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | Idelalisib: Predose Week 3 | 90.25 ng/mL | Standard Deviation 85.374 |
| Cohort B, Idelalisib + Ruxolitinib | Plasma Concentration of Idelalisib and GS-563117 (Idelalisib Metabolite) | GS-563117: Predose Week 3 | 988.0 ng/mL | Standard Deviation 1018.05 |
Secondary
Rate of Overall Response
Rate of overall response as defined by 2013 Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
Time frame: Start of treatment to end of treatment ( up to 15.1 months)
Population: The study was prematurely terminated due to safety measures. Complete data were not collected for any participant.