NCT01796470 · OUTCOME

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies · Source last updated 2020-06-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: First dose date up to the last dose date plus 30 days (maximum: 18 months)

What was measured

A treatment-emergent laboratory (Hematology, Serum Chemistry and Urinalysis) abnormality was defined as an abnormality that, compared to baseline, worsens by ≥ 1 grade in the period from the first dose of study drug. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 0 = none, Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening or disabling. If baseline data are missing, then any graded abnormality (i.e., an abnormality that is Grade ≥ 1 in severity) will be considered treatment-emergent. The percentage of participants in each worst postbaseline grade is reported.

Analysis population: Participants in the Safety Analysis Set were analyzed.

Groups in this outcome

Entospletinib + Idelalisib CLL

Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.

Entospletinib + Idelalisib iNHL: FL

Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.

Entospletinib + Idelalisib DLBCL

Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.

Entospletinib + Idelalisib MCL

Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.

Entospletinib + Idelalisib iNHL: Others

Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/ Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Entospletinib + Idelalisib CLL	35
Entospletinib + Idelalisib iNHL: FL	14
Entospletinib + Idelalisib DLBCL	6
Entospletinib + Idelalisib MCL	3
Entospletinib + Idelalisib iNHL: Others	8

Reported measurements

Neutrophils Count Decreased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	17.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	21.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	66.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	25.0	Not reported	Not reported	Not reported	Not reported

Neutrophils Count Decreased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	20.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	25.0	Not reported	Not reported	Not reported	Not reported

Neutrophils Count Decreased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Neutrophils Count Decreased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	11.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	25.0	Not reported	Not reported	Not reported	Not reported

Anemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	20.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	35.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Anemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Anemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Anemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Leukocytosis (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Leukocytosis (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Leukocytosis (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Leukocytosis (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

White Blood Cell Count Decreased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	21.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

WBC Count Decreased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

WBC Count Decreased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

WBC Count Decreased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Decreased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Decreased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Decreased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	21.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	50.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Decreased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Increased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Increased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	8.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Increased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Increased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Platelets Count Decreased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	11.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Platelets Count Decreased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Platelets Count Decreased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Platelets Count Decreased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase (ALT) Increased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	22.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	50.0	Not reported	Not reported	Not reported	Not reported

ALT Increased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	8.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

ALT Increased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	35.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

ALT Increased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase (ALP) Increased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	17.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

ALP Increased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

ALP Increased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

ALP Increased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase (AST)Increased(Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	20.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	50.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	37.5	Not reported	Not reported	Not reported	Not reported

AST Increased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

AST Increased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	28.6	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

AST Increased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Chronic Kidney Disease (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	34.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	42.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	50.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	37.5	Not reported	Not reported	Not reported	Not reported

Chronic Kidney Disease (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Chronic Kidney Disease (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Chronic Kidney Disease (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	11.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	11.4	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypoglycemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	25.0	Not reported	Not reported	Not reported	Not reported

Hypoglycemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypoglycemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypoglycemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	20.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	33.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	20.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	50.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	5.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	25.0	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Blood Bilirubin Increased (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	17.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	50.0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Blood Bilirubin Increased (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	25.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	16.7	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Blood Bilirubin Increased (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Blood Bilirubin Increased (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Proteinuria (Grade 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	22.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	7.1	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	12.5	Not reported	Not reported	Not reported	Not reported

Proteinuria (Grade 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	2.9	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	14.3	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	0	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	0	Not reported	Not reported	Not reported	Not reported

Proteinuria (Grade 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Proteinuria (Grade 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Entospletinib + Idelalisib CLL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: FL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib DLBCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib MCL	Not reported	Not reported	Not reported	Not reported
Entospletinib + Idelalisib iNHL: Others	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
17.1
group Id
OG001
value
21.4
group Id
OG002
value
0
group Id
OG003
value
66.7
group Id
OG004
value
25.0
title
Neutrophils Count Decreased (Grade 1)
categories
measurements
group Id
OG000
value
20.0
group Id
OG001
value
14.3
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
25.0
title
Neutrophils Count Decreased (Grade 2)
categories
measurements
group Id
OG000
value
14.3
group Id
OG001
value
7.1
group Id
OG002
value
16.7
group Id
OG003
value
0
group Id
OG004
value
0
title
Neutrophils Count Decreased (Grade 3)
categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
7.1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
25.0
title
Neutrophils Count Decreased (Grade 4)
categories
measurements
group Id
OG000
value
20.0
group Id
OG001
value
35.7
group Id
OG002
value
16.7
group Id
OG003
value
0
group Id
OG004
value
0
title
Anemia (Grade 1)
categories
measurements
group Id
OG000
value
14.3
group Id
OG001
value
7.1
group Id
OG002
value
16.7
group Id
OG003
value
0
group Id
OG004
value
0
title
Anemia (Grade 2)
categories
measurements
group Id
OG000
value
5.7
group Id
OG001
value
0
group Id
OG002
value
16.7
group Id
OG003
value
0
group Id
OG004
value
0
title
Anemia (Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Anemia (Grade 4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Leukocytosis (Grade 1)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Leukocytosis (Grade 2)
categories
measurements
group Id
OG000
value
28.6
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
33.3
group Id
OG004
value
0
title
Leukocytosis (Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Leukocytosis (Grade 4)

denoms

counts
group Id
OG000
value
35
group Id
OG001
value
14
group Id
OG002
value
6
group Id
OG003
value
3
group Id
OG004
value
8
units
Participants

description

groups

description
Participants with a documented diagnosis of chronic lymphocytic leukemia (CLL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
OG000
title
Entospletinib + Idelalisib CLL
description
Participants with a documented diagnosis of indolent non-Hodgkin lymphoma (iNHL) with follicular lymphoma (FL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
OG001
title
Entospletinib + Idelalisib iNHL: FL
description
Participants with a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred ,increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
OG002
title
Entospletinib + Idelalisib DLBCL
description
Participants with a documented diagnosis of mantle cell lymphoma (MCL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) occurred, increased dose to 600 mg/100 mg for 2 weeks, if no DLT occurred, increased dose to 800 mg/100 mg for 4 weeks, if no DLT occurred, increased dose to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
OG003
title
Entospletinib + Idelalisib MCL
description
Participants with a documented diagnosis of iNHL with other subtypes lymphoplasmacytic lymphoma (LPL)/ Waldenstrom macroglobulinemia (WM), small lymphocytic lymphoma (SLL), and marginal zone lymphoma (MZL) were included in this arm. Participants were administered 4 dose combinations of entospletinib plus idelalisib tablets orally twice daily under fasted conditions (400 mg/100 mg for 2 weeks, if no dose limiting toxicity (DLT) increased to 600 mg/100 mg for 2 weeks, if no DLT increased to 800 mg/100 mg for 4 weeks, if no DLT increased to 800 mg/150 mg) for up to 6 months. After discontinuation of combination therapy and a washout period of 14-28 days, participants could continue to receive entospletinib 400 mg monotherapy for up to 18 months.
id
OG004
title
Entospletinib + Idelalisib iNHL: Others

param Type

NUMBER

population Description

Participants in the Safety Analysis Set were analyzed.

reporting Status

POSTED

time Frame

First dose date up to the last dose date plus 30 days (maximum: 18 months)

title

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice