Chronic Lymphocytic Leukemia, Follicular Lymphoma, Indolent Non-Hodgkin Lymphoma, Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia), Marginal Zone Lymphoma, Small Lymphocytic Lymphoma
Conditions
Brief summary
The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).
Interventions
DRUGIdelalisib
150 mg tablet(s) administered orally twice daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants with mature B-cell malignancies of iNHL including follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and CLL by World Health Organization classification * Must have been born in Japan and must not have lived outside of Japan for \> 1 year in the 5 years prior to Day 1 * Must be able to trace maternal and paternal ancestry of parents and grandparents as Japanese * Must have been previously treated with at least 1 regimen for iNHL or CLL and currently require treatment * Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1 * Eastern Cooperative Oncology Group performance status of 0 or 1 * Required baseline laboratory data (within 4 weeks prior to Day 1) * A negative serum pregnancy test for female participants of childbearing potential * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's disease. Key
Exclusion criteria
* Known histological transformation to an aggressive histology * Known presence of myelodysplastic syndrome * History of iNHL or CLL with central nervous system involvement * Life expectancy \< 120 days as per investigator assessment * History of a nonlymphoid malignancy with the following exceptions: * the malignancy has been in remission without treatment for ≥ 5 years prior to Day 1, or * carcinoma in situ of the cervix, or * adequately treated basal or squamous cell skin cancer or other localized nonmelanoma skin cancer, or * surgically treated low-grade prostate cancer, or * ductal carcinoma in situ of the breast treated with lumpectomy alone * On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension * History or diagnosis of pneumonitis or interstitial lung disease. * On-going inflammatory bowel disease * Pregnancy or breastfeeding * History of prior allogeneic hematopoietic stem cell or solid organ transplantation * Concurrent participation in another therapeutic clinical trial * Prior or on-going clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29 | — |
| Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 | Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both. |
| Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | Predose and 1.5 hours postdose on Day 8 | — |
| Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | Predose and 1.5 hours postdose on Day 15 | — |
| Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | Predose and 1.5 hours postdose on Day 22 | — |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| 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. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent.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 a TEAE Within 28 Days of Idelalisib Exposure | First dose date up to 28 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure | First dose date up to 30 days after last dose (up to approximately 3 years) | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | First dose date up to 30 days after last dose (up to approximately 3 years) | 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 CTCAE, Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. |
| Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure | First dose date up to 30 days after last dose (up to approximately 3 years) | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
| Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure | First dose date up to 30 days after last dose (up to approximately 3 years) | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled at study sites in Japan. The first participant was screened on 01 October 2014. The last study visit occurred on 17 October 2017.
Pre-assignment details
6 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Idelalisib Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Initiated another anti-cancer or experimental therapy | 2 |
| Overall Study | Investigator's Discretion | 1 |
| Overall Study | Progressive Disease | 2 |
| Overall Study | Unable to tolerate rechallenge with idelalisib | 1 |
Baseline characteristics
| Characteristic | Idelalisib |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 5 / 6 |
Outcome results
Primary
Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 28 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure | 0 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 28 days
Population: The Full Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | TEAEs | 66.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure | SAEs | 16.7 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. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent.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) |
|---|---|---|---|
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 4) | 0 percentage of participants |
| Idelalisib | 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) | 16.7 percentage of participants |
| Idelalisib | 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 |
| Idelalisib | 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) | 16.7 percentage of participants |
| Idelalisib | 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 |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 16.7 percentage of participants |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 4) | 0 percentage of participants |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | 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 |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 2) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 4) | 0 percentage of participants |
Primary
Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 28 days
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure | 0 percentage of participants |
Primary
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both.
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1
Population: The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose value reported by the PK laboratory.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: Predose | NA ng/mL | — |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 0.5 hour | 188.4 ng/mL | Standard Deviation 322.97 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 1 hour | 763.9 ng/mL | Standard Deviation 1141.85 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 1.5 hour | 1454.0 ng/mL | Standard Deviation 1255.23 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 2 hour | 2097.4 ng/mL | Standard Deviation 1483.25 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 3 hour | 2226.5 ng/mL | Standard Deviation 1231.66 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 4 hour | 2042.3 ng/mL | Standard Deviation 1048.57 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 6 hour | 1215.0 ng/mL | Standard Deviation 797.5 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 8 hour | 718.5 ng/mL | Standard Deviation 532.06 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | Idelalisib: 12 hour | 291.4 ng/mL | Standard Deviation 247.66 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: Predose | NA ng/mL | — |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 0.5 hour | 6.38 ng/mL | Standard Deviation 7.095 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 1 hour | 134.92 ng/mL | Standard Deviation 153.644 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 1.5 hour | 478.75 ng/mL | Standard Deviation 507.114 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 2 hour | 1005.12 ng/mL | Standard Deviation 781.188 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 3 hour | 2011.00 ng/mL | Standard Deviation 1206.687 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 4 hour | 2121.00 ng/mL | Standard Deviation 1352.57 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 6 hour | 2288.33 ng/mL | Standard Deviation 1358.446 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 8 hour | 2195.00 ng/mL | Standard Deviation 1494.054 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 | GS-563117: 12 hour | 1677.83 ng/mL | Standard Deviation 1307.384 |
Primary
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15
Time frame: Predose and 1.5 hours postdose on Day 15
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | Idelalisib: Predose | 459.3 ng/mL | Standard Deviation 203.64 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | Idelalisib: 1.5 hour | 2648.3 ng/mL | Standard Deviation 1601.7 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | GS-563117: Predose | 3326.67 ng/mL | Standard Deviation 2655.234 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 | GS-563117: 1.5 hour | 3636.67 ng/mL | Standard Deviation 2547.883 |
Primary
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22
Time frame: Predose and 1.5 hours postdose on Day 22
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | Idelalisib: Predose | 358.7 ng/mL | Standard Deviation 237.86 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | Idelalisib: 1.5 hour | 2155.0 ng/mL | Standard Deviation 782.73 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | GS-563117: Predose | 2318.33 ng/mL | Standard Deviation 1070.111 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 | GS-563117: 1.5 hour | 2828.33 ng/mL | Standard Deviation 1749.153 |
Primary
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: Predose | 501.2 ng/mL | Standard Deviation 329.02 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 0.5 hour | 666.8 ng/mL | Standard Deviation 454.58 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 1 hour | 1107.8 ng/mL | Standard Deviation 891.69 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 1.5 hour | 1523.3 ng/mL | Standard Deviation 990.84 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 2 hour | 1940.0 ng/mL | Standard Deviation 1028.47 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 3 hour | 2313.3 ng/mL | Standard Deviation 644.13 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 4 hour | 1843.8 ng/mL | Standard Deviation 701.36 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 6 hour | 1141.2 ng/mL | Standard Deviation 509.7 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 8 hour | 707.2 ng/mL | Standard Deviation 340.26 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | Idelalisib: 12 hour | 403.0 ng/mL | Standard Deviation 315.41 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: Predose Day 29 | 3075.00 ng/mL | Standard Deviation 2546.698 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 0.5 hour | 2913.33 ng/mL | Standard Deviation 2855.182 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 1 hour | 2833.33 ng/mL | Standard Deviation 2535.387 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 1.5 hour | 2930.00 ng/mL | Standard Deviation 2585.66 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 2 hour | 3185.00 ng/mL | Standard Deviation 2799.691 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 3 hour | 3781.67 ng/mL | Standard Deviation 3058.283 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 4 hour | 3893.33 ng/mL | Standard Deviation 2996.309 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 6 hour | 3653.33 ng/mL | Standard Deviation 2900.232 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 8 hour | 3428.33 ng/mL | Standard Deviation 2987.376 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 | GS-563117: 12 hour | 2871.67 ng/mL | Standard Deviation 3309.601 |
Primary
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8
Time frame: Predose and 1.5 hours postdose on Day 8
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | Idelalisib: Predose | 463.2 ng/mL | Standard Deviation 220.75 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | Idelalisib: 1.5 hour | 2138.5 ng/mL | Standard Deviation 759.23 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | GS-563117: Predose | 2703.33 ng/mL | Standard Deviation 1866.555 |
| Idelalisib | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 | GS-563117: 1.5 hour | 3040.00 ng/mL | Standard Deviation 1736.237 |
Secondary
Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 30 days after last dose (up to approximately 3 years)
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Idelalisib | Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure | TEAEs | 100.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure | SAEs | 83.3 percentage of participants |
Secondary
Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 30 days after last dose (up to approximately 3 years)
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure | 83.3 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-Emergent 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 CTCAE, Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Time frame: First dose date up to 30 days after last dose (up to approximately 3 years)
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Anemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Leukocytosis (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 1) | 50.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | White blood cell decreased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Lymphocyte count decreased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 3) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Neutrophil count decreased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alanine aminotransferase increased (Grade 4) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoalbuminemia (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoalbuminemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoalbuminemia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypoalbuminemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypocalcemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 1) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Alkaline phosphatase increased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Aspartate aminotransferase increased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 1) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Blood bilirubin increased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 1) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Cholesterol high (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 1) | 50.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Creatinine increased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 2) | 50.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Chronic Kidney Disease (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase increased (Grade 1) | 50.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase increased (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase increased (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Gamma Glutamyl Transferase increased (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 1) | 50.0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperglycemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypophosphatemia (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypophosphatemia (Grade 2) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypophosphatemia (Grade 3) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypophosphatemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 1) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 3) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypokalemia (Grade 4) | 16.7 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyponatremia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 3) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hypertriglyceridemia (Grade 4) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 1) | 33.3 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 2) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 3) | 0 percentage of participants |
| Idelalisib | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline | Hyperuricemia (Grade 4) | 0 percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 30 days after last dose (up to approximately 3 years)
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure | 16.7 percentage of participants |