Trial Outcomes & Findings for Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies (NCT NCT01796470)
NCT ID: NCT01796470
Last Updated: 2020-06-02
Results Overview
ORR assessed by the Independent Review Committee (IRC), was based on the International Working Group Revised Response Criteria (Cheson, 2012) and investigator's response, defined as the percentage of participants achieving a complete response (CR) or partial response (PR) (or very good partial response \[VGPR\] or minor response \[MR\] for participants with LPL/WM). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal immunoglobulin M (IgM) concentration by serum protein electrophoresis (SPEP) respectively.
TERMINATED
PHASE2
66 participants
Start of treatment to end of treatment (Up to 18 months)
2020-06-02
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 20 June 2013. The last study visit occurred on 22 December 2016.
85 participants were screened.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
14
|
6
|
3
|
8
|
|
Overall Study
Entospletinib Monotherapy
|
4
|
4
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
14
|
6
|
3
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
2
|
1
|
3
|
|
Overall Study
Death
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Initiated New Therapy
|
9
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
5
|
4
|
1
|
0
|
1
|
|
Overall Study
Progressive Disease
|
7
|
7
|
3
|
2
|
0
|
|
Overall Study
Protocol Criteria for Withdrawal
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Entospletinib + Idelalisib CLL
n=35 Participants
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
n=14 Participants
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
n=6 Participants
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
n=3 Participants
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
n=8 Participants
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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
64 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
69 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
69 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
67 years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Karnofsky Performance Status
40
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Karnofsky Performance Status
50
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Karnofsky Performance Status
60
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Karnofsky Performance Status
70
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Karnofsky Performance Status
80
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Karnofsky Performance Status
90
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Karnofsky Performance Status
100
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to end of treatment (Up to 18 months)Population: The study was terminated due to safety measures. Complete data was not collected for any participant.
ORR assessed by the Independent Review Committee (IRC), was based on the International Working Group Revised Response Criteria (Cheson, 2012) and investigator's response, defined as the percentage of participants achieving a complete response (CR) or partial response (PR) (or very good partial response \[VGPR\] or minor response \[MR\] for participants with LPL/WM). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal immunoglobulin M (IgM) concentration by serum protein electrophoresis (SPEP) respectively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum duration: 19 months)Population: The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
A treatment-emergent Adverse Event (AE) was defined as any AE with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drugs or an AE leading to premature discontinuation of study drug. An AE is any untoward medical occurrence in a clinical investigation where participants administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Entospletinib + Idelalisib CLL
n=35 Participants
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
n=14 Participants
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
n=6 Participants
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
n=3 Participants
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
n=8 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 18 months)Population: Participants in the Safety Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Entospletinib + Idelalisib CLL
n=35 Participants
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
n=14 Participants
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
n=6 Participants
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
n=3 Participants
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
n=8 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALP Increased (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Neutrophils Count Decreased (Grade 1)
|
17.1 percentage of participants
|
21.4 percentage of participants
|
0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Neutrophils Count Decreased (Grade 2)
|
20.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Neutrophils Count Decreased (Grade 3)
|
14.3 percentage of participants
|
7.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Neutrophils Count Decreased (Grade 4)
|
11.4 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Anemia (Grade 1)
|
20.0 percentage of participants
|
35.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Anemia (Grade 2)
|
14.3 percentage of participants
|
7.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Anemia (Grade 3)
|
5.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Anemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Leukocytosis (Grade 1)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Leukocytosis (Grade 2)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Leukocytosis (Grade 3)
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Leukocytosis (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
White Blood Cell Count Decreased (Grade 1)
|
0 percentage of participants
|
21.4 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
WBC Count Decreased (Grade 2)
|
14.3 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
WBC Count Decreased (Grade 3)
|
5.7 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
WBC Count Decreased (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 1)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 2)
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 3)
|
5.7 percentage of participants
|
21.4 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Increased (Grade 1)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Increased (Grade 2)
|
8.6 percentage of participants
|
7.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Increased (Grade 3)
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Lymphocyte Count Increased (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Platelets Count Decreased (Grade 1)
|
11.4 percentage of participants
|
28.6 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Platelets Count Decreased (Grade 2)
|
2.9 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Platelets Count Decreased (Grade 3)
|
5.7 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Platelets Count Decreased (Grade 4)
|
2.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Alanine Aminotransferase (ALT) Increased (Grade 1)
|
22.9 percentage of participants
|
7.1 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALT Increased (Grade 2)
|
8.6 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALT Increased (Grade 3)
|
0 percentage of participants
|
35.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALT Increased (Grade 4)
|
5.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoalbuminemia (Grade 1)
|
14.3 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoalbuminemia (Grade 2)
|
5.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoalbuminemia (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoalbuminemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Alkaline Phosphatase (ALP) Increased (Grade 1)
|
17.1 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALP Increased (Grade 2)
|
2.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
ALP Increased (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Aspartate Aminotransferase (AST)Increased(Grade 1)
|
20.0 percentage of participants
|
14.3 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
AST Increased (Grade 2)
|
2.9 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
AST Increased (Grade 3)
|
0 percentage of participants
|
28.6 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
AST Increased (Grade 4)
|
5.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Chronic Kidney Disease (Grade 1)
|
34.3 percentage of participants
|
42.9 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Chronic Kidney Disease (Grade 2)
|
0 percentage of participants
|
7.1 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Chronic Kidney Disease (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Chronic Kidney Disease (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyperglycemia (Grade 1)
|
11.4 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyperglycemia (Grade 2)
|
5.7 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyperglycemia (Grade 3)
|
11.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyperglycemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoglycemia (Grade 1)
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoglycemia (Grade 2)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoglycemia (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypoglycemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypophosphatemia (Grade 1)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypophosphatemia (Grade 2)
|
2.9 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypophosphatemia (Grade 3)
|
5.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypophosphatemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypokalemia (Grade 1)
|
20.0 percentage of participants
|
7.1 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypokalemia (Grade 2)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypokalemia (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hypokalemia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyponatremia (Grade 1)
|
20.0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyponatremia (Grade 2)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyponatremia (Grade 3)
|
5.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Hyponatremia (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Blood Bilirubin Increased (Grade 1)
|
17.1 percentage of participants
|
14.3 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Blood Bilirubin Increased (Grade 2)
|
25.7 percentage of participants
|
14.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Blood Bilirubin Increased (Grade 3)
|
2.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Blood Bilirubin Increased (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Proteinuria (Grade 1)
|
22.9 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Proteinuria (Grade 2)
|
2.9 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Proteinuria (Grade 3)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Proteinuria (Grade 4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose (entospelinib + idelalisib) date up to 6 monthsPopulation: The study was terminated due to safety measures. Complete data was not collected for any participant.
Maximum tolerated dose (MTD) is defined as the highest dose level that was consistently well tolerated without dose limiting toxicity (DLT) for the majority of participants time on treatment (ie,\> 50%) as determined by the investigator for each participant. DLTs are defined as Grade 4 hematological toxicities persisting for ≥ 14 days or Grade ≥ 3 toxicities of other types.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to end of treatment (Up to 18 months)Population: The study was terminated due to safety measures. Complete data was not collected for any participant.
PFS was defined as the interval from the first dose of study drug to the earlier of the first documentation of definitive disease progression or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to end of treatment (Up to 18 months)Population: The study was terminated due to safety measures. Complete data was not collected for any participant.
DOR was defined as the interval from the first-time response (CR or PR \[or VGPR or MR for participants with LPL/WM\]) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause.CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal IgM concentration by SPEP respectively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to end of treatment (Up to 18 months)Population: The study was terminated due to safety measures. Complete data was not collected for any participant.
TTR was defined as the interval from the first dose of entospletinib/idelalisib to the time response (CR or PR \[or VGPR or MR for participants with LPL/WM\]) is first achieved. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal IgM concentration by SPEP respectively.
Outcome measures
Outcome data not reported
Adverse Events
Entospletinib + Idelalisib CLL
Entospletinib + Idelalisib iNHL: FL
Entospletinib + Idelalisib DLBCL
Entospletinib + Idelalisib MCL
Entospletinib + Idelalisib iNHL: Others
Serious adverse events
| Measure |
Entospletinib + Idelalisib CLL
n=35 participants at risk
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
n=14 participants at risk
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
n=6 participants at risk
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
n=3 participants at risk
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
n=8 participants at risk
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.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Drug interaction
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Pyrexia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Bacteraemia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Fungal infection
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Pneumonia
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
International normalised ratio increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Lymphocyte count increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Altered state of consciousness
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
22.9%
8/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
Other adverse events
| Measure |
Entospletinib + Idelalisib CLL
n=35 participants at risk
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
n=14 participants at risk
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
n=6 participants at risk
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
n=3 participants at risk
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
n=8 participants at risk
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.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Cardiac disorders
Palpitations
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Constipation
|
31.4%
11/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
14/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
28.6%
4/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
22.9%
8/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Nausea
|
40.0%
14/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
50.0%
7/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
66.7%
4/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Asthenia
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Catheter site pain
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Chest discomfort
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Chest pain
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Chills
|
20.0%
7/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
50.0%
3/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Discomfort
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Fatigue
|
42.9%
15/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
42.9%
6/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
66.7%
4/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
37.5%
3/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Malaise
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Oedema peripheral
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Pain
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Peripheral swelling
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
General disorders
Pyrexia
|
28.6%
10/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
35.7%
5/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
83.3%
5/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Hepatobiliary disorders
Jaundice
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Cellulitis
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Conjunctivitis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Localised infection
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Sinusitis
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
6/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Alanine aminotransferase increased
|
17.1%
6/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
28.6%
4/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
7/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
28.6%
4/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Blood creatinine increased
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Blood glucose increased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Neutrophil count decreased
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Urine output decreased
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
Weight decreased
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
66.7%
4/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
21.4%
3/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Dizziness
|
14.3%
5/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Headache
|
25.7%
9/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
28.6%
4/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
66.7%
2/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Neuropathy peripheral
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Paraesthesia
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Depression
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Insomnia
|
17.1%
6/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
10/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
4/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
66.7%
2/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
17.1%
6/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
7/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
2/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
2/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
25.0%
2/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
14.3%
2/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Vascular disorders
Flushing
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
16.7%
1/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
12.5%
1/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/35 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
7.1%
1/14 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/6 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
0.00%
0/8 • First dose date up to the last dose date plus 30 days (maximum duration: 19 months); All-Cause Mortality: Baseline to Last Follow-Up Visit (Up to 3.6 years)
The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib).
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER