Trial Outcomes & Findings for Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT NCT02077166)
NCT ID: NCT02077166
Last Updated: 2022-02-04
Results Overview
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
138 participants
Primary outcome timeframe
Estimated median time on study in Phase 1b was 59.6 months.
Results posted on
2022-02-04
Participant Flow
All participants had relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In the Phase 1b portion of the study, all subtypes of DLBCL and participants with transformed disease were enrolled. In the Phase 2 portion of the study, only participants with non-germinal-center B-cell-like (non-GCB) DLBCL were enrolled.
In the Phase 1b portion of this study, different dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A total of 138 participants enrolled in the study; however, 4 participants exited the study without receiving any treatment, and are not presented in any data table.
Participant milestones
| Measure |
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
9
|
9
|
8
|
55
|
34
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
9
|
9
|
8
|
55
|
34
|
Reasons for withdrawal
| Measure |
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
6
|
7
|
5
|
6
|
4
|
32
|
22
|
|
Overall Study
Study Closure by Sponsor
|
3
|
0
|
2
|
2
|
2
|
12
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
1
|
1
|
3
|
0
|
|
Overall Study
Other, Not Specified
|
0
|
0
|
1
|
0
|
1
|
7
|
8
|
Baseline Characteristics
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
n=12 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 20 mg
n=55 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 25 mg
n=34 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 8.63 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 14.23 • n=21 Participants
|
63.1 years
STANDARD_DEVIATION 11.75 • n=8 Participants
|
64.9 years
STANDARD_DEVIATION 12.52 • n=8 Participants
|
63.9 years
STANDARD_DEVIATION 11.88 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
57 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
77 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
124 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
121 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
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=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Declined to Answer/Unknown
|
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=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Estimated median time on study in Phase 1b was 59.6 months.Population: All-Treated Analysis Population (Phase 1b): participants who received any dose of study drug(s).
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
Outcome measures
| Measure |
All Phase 1b Participants
n=45 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
|
20 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0.Population: All-Treated Analysis Population (Phase 1): participants who received any dose of study drug(s).
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization \> 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
Outcome measures
| Measure |
All Phase 1b Participants
n=12 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE
|
12 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 TEAE
|
11 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Any Study Drug
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Ibrutinib Dose
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Lenalidomide Dose
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Rituximab Dose
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Serious TEAE
|
4 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Serious TEAE
|
4 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Treatment-Related Serious TEAE
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Ibrutinib-Related Serious TEAE
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Lenalidomide-Related Serious TEAE
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Rituximab-Related Serious TEAE
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Fatal TEAE
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Study Drug-Related TEAE
|
12 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Study Drug-Related TEAE
|
10 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Ibrutinib-Related TEAE
|
12 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Ibrutinib-Related TEAE
|
10 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Lenalidomide-Related TEAE
|
12 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Lenalidomide-Related TEAE
|
9 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Rituximab-Related TEAE
|
6 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >= 3 Rituximab-Related TEAE
|
1 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Any Study Drug
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Ibrutinib
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Lenalidomide
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Any Study Drug
|
6 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Ibrutinib
|
6 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Lenalidomide
|
6 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
—
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Rituximab
|
4 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Estimated median time on study in Phase 2 was 35.0 months.Population: Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
The ORR was defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014), as assessed by the investigator in response-evaluable population. The 95% confidence interval (CI) was calculated using the exact method.
Outcome measures
| Measure |
All Phase 1b Participants
n=53 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=32 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=85 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR)
|
52.8 percentage of participants
Interval 38.6 to 66.7
|
43.8 percentage of participants
Interval 26.4 to 62.3
|
49.4 percentage of participants
Interval 38.4 to 60.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated median time on study in Phase 1b was 59.6 months.Population: Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
The ORR was defined as the percentage of participants who achieve either a PR or CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. The 95% CI was calculated using the exact method.
Outcome measures
| Measure |
All Phase 1b Participants
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
n=40 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 1b: ORR
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
0 percentage of participants
Interval 0.0 to 41.0
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
42.5 percentage of participants
Interval 27.0 to 59.1
|
SECONDARY outcome
Timeframe: Estimated median time on Phase 1b study was 59.6 months.Population: Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease, as assessed by the Investigator.
Outcome measures
| Measure |
All Phase 1b Participants
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=7 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
n=40 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 1b: Complete Response (CR) Rate
|
33.3 percentage of participants
|
0 percentage of participants
|
42.9 percentage of participants
|
11.1 percentage of participants
|
50.0 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: Estimated median time on study in Phase 2 was 35.0 months.Population: Response-Evaluable Population: participants who had measurable disease at baseline and had at least 1 adequate post-treatment disease assessment by the investigator.
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (see Cheson, 2014 for detailed criteria) in response-evaluable population, as assessed by the Investigator.
Outcome measures
| Measure |
All Phase 1b Participants
n=53 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=32 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=89 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: CR Rate
|
32.1 percentage of participants
|
21.9 percentage of participants
|
28.2 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated median time on study in Phase 2 was 35.0 months.Population: All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s). Participant who achieved Overall Response.
DOR is defined as the time from the date of the first documented response (CR or PR) to the first documented evidence of disease progression (PD) according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause. For participants who had achieved an overall response but did not die or progress at the time of analysis, DOR was censored on the date of the last adequate post-baseline disease assessment, or on the date of the first occurrence of response (CR or PR) if there was no disease assessment afterwards. 2-sided 95% CI is estimated by Kaplan-Meier method.
Outcome measures
| Measure |
All Phase 1b Participants
n=28 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=14 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=42 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
|
38.3 months
Interval 3.7 to
The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
|
28.6 months
Interval 2.8 to 28.6
|
38.3 months
Interval 9.5 to
The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated median time on study in Phase 2 was 35.0 months.Population: All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
PFS is defined as the time from the date of the first dose of study drug to confirmed PD according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause, whichever occurred first. For participants without disease progression or death, PFS data was censored at the date of the last tumor assessment. 2 sided 95% CI is estimated by Kaplan-Meier method.
Outcome measures
| Measure |
All Phase 1b Participants
n=55 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=34 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=89 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
|
5.4 months
Interval 3.4 to 11.3
|
4.7 months
Interval 2.6 to 24.8
|
5.4 months
Interval 3.4 to 6.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated median time on study in Phase 2 was 35.0 months.Population: All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
OS is defined as the time from the date of the first dose of study drug to the date of death due to any cause. For participants not known to have died at or prior to the database lock date, OS data was censored at the date last known alive. Participants who withdrew consent prior to study closure were censored on the date of the consent withdrawal. 2-sided 95% CI was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
All Phase 1b Participants
n=55 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=34 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=89 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
14.7 months
Interval 9.7 to 32.8
|
11.6 months
Interval 5.7 to
The upper confidence limit is not estimable per the Brookmeyer and Crowley (1982) method.
|
14.2 months
Interval 9.7 to 28.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.Population: All-Treated Analysis Population (Phase 2): participants who received any dose of study drug(s).
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization \> 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events were those that were considered possibly related or related to study drug per investigator's judgment. Events were graded per the national Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03: Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening; grade 5=death.
Outcome measures
| Measure |
All Phase 1b Participants
n=55 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=34 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=89 Participants
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE
|
55 Participants
|
34 Participants
|
89 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 TEAE
|
51 Participants
|
30 Participants
|
81 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Study Drug-Related TEAE
|
52 Participants
|
33 Participants
|
85 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Study Drug-Related TEAE
|
41 Participants
|
25 Participants
|
66 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Ibrutinib-Related TEAE
|
50 Participants
|
32 Participants
|
82 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Ibrutinib-Related TEAE
|
36 Participants
|
24 Participants
|
60 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Lenalidomide-Related TEAE
|
51 Participants
|
32 Participants
|
83 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Lenalidomide-Related TEAE
|
40 Participants
|
25 Participants
|
65 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Rituximab-Related TEAE
|
37 Participants
|
25 Participants
|
62 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >= 3 Rituximab-Related TEAE
|
18 Participants
|
13 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Any Study Drug
|
23 Participants
|
14 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Ibrutinib
|
12 Participants
|
9 Participants
|
21 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Reduction of Lenalidomide
|
21 Participants
|
14 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Any Study Drug
|
40 Participants
|
29 Participants
|
69 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Ibrutinib
|
38 Participants
|
28 Participants
|
66 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Lenalidomide
|
37 Participants
|
26 Participants
|
63 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Dose Delay of Rituximab
|
10 Participants
|
6 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Any Study Drug
|
11 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Ibrutinib Dose
|
11 Participants
|
5 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Lenalidomide Dose
|
11 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any TEAE Leading to Discontinuation of Rituximab Dose
|
6 Participants
|
4 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Serious TEAE
|
32 Participants
|
25 Participants
|
57 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Grade >=3 Serious TEAE
|
29 Participants
|
21 Participants
|
50 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Treatment-Related Serious TEAE
|
16 Participants
|
12 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Ibrutinib-Related Serious TEAE
|
14 Participants
|
12 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Lenalidomide-Related Serious TEAE
|
16 Participants
|
10 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Rituximab-Related Serious TEAE
|
4 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs
Any Fatal TEAE
|
8 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
—
|
Adverse Events
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 7 deaths
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
Serious events: 7 serious events
Other events: 9 other events
Deaths: 5 deaths
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 7 deaths
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 5 deaths
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Serious events: 32 serious events
Other events: 54 other events
Deaths: 33 deaths
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Serious events: 25 serious events
Other events: 34 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
n=12 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=9 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles
|
Phase 2: Enrolled at Lenalidomide Dose 20 mg
n=55 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 25 mg
n=34 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GASTROSPLENIC FISTULA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
ASTHENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
CHILLS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
FATIGUE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
PYREXIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
GALLBLADDER ENLARGEMENT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CELLULITIS ORBITAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
HAEMATOMA INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SALMONELLA BACTERAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
WOUND SEPSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OCULAR LYMPHOMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
EMBOLIC CEREBRAL INFARCTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
DELIRIUM
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Reproductive system and breast disorders
PROSTATIC OBSTRUCTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
Other adverse events
| Measure |
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
n=12 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
n=7 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
n=9 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
n=9 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
n=8 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles
|
Phase 2: Enrolled at Lenalidomide Dose 20 mg
n=55 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
Phase 2: Enrolled at Lenalidomide Dose 25 mg
n=34 participants at risk
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
General disorders
PAIN
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
OEDEMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
OEDEMA PERIPHERAL
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
50.0%
4/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
38.2%
21/55 • Number of events 30 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
23.5%
8/34 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
PERIPHERAL SWELLING
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
PYREXIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
VESSEL PUNCTURE SITE BRUISE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
HEPATIC CYST
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
BLISTER INFECTED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CLOSTRIDIUM COLITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CONJUNCTIVITIS BACTERIAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CORONAVIRUS INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
CYSTITIS KLEBSIELLA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
EYE INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
FOLLICULITIS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
HERPES ZOSTER
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
IMPETIGO
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
NAIL INFECTION
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PNEUMONIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
PUSTULE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SINUSITIS
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SINUSITIS BACTERIAL
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.7%
2/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
21.8%
12/55 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
WOUND ABSCESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
16.7%
2/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
10.9%
6/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
EYE CONTUSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
FALL
|
16.7%
2/12 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
IMPACTED FRACTURE
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
SCRATCH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
16.7%
2/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.3%
4/12 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
30.9%
17/55 • Number of events 88 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
32.4%
11/34 • Number of events 16 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
16.7%
2/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.5%
8/55 • Number of events 13 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
8.3%
1/12 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 35 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
41.7%
5/12 • Number of events 13 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
66.7%
6/9 • Number of events 46 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
62.5%
5/8 • Number of events 41 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
45.5%
25/55 • Number of events 126 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
41.2%
14/34 • Number of events 68 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
33.3%
4/12 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 21 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.0%
11/55 • Number of events 61 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
29.4%
10/34 • Number of events 36 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
METAMORPHOPSIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Cardiac disorders
TACHYCARDIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Ear and labyrinth disorders
VERTIGO
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
CATARACT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
CHALAZION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
DRY AGE-RELATED MACULAR DEGENERATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
DRY EYE
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
10.9%
6/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
17.6%
6/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
EXOPHTHALMOS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
EYE OEDEMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
EYE PRURITUS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
LACRIMATION INCREASED
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
OPTIC NERVE COMPRESSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
PERIORBITAL SWELLING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
TRICHIASIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
16.4%
9/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
CONSTIPATION
|
41.7%
5/12 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.0%
11/55 • Number of events 17 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
29.4%
10/34 • Number of events 13 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
DEFAECATION URGENCY
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
DIARRHOEA
|
75.0%
9/12 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
42.9%
3/7 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
87.5%
7/8 • Number of events 16 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
58.2%
32/55 • Number of events 83 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
38.2%
13/34 • Number of events 29 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.5%
8/55 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
23.5%
8/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
FLATULENCE
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GINGIVAL SWELLING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
HYPERCHLORHYDRIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
NAUSEA
|
58.3%
7/12 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
42.9%
3/7 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
50.0%
4/8 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
30.9%
17/55 • Number of events 20 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
26.5%
9/34 • Number of events 15 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ORAL DISORDER
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
ORAL PAIN
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
STOMATITIS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 17 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
TONGUE ULCERATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
TOOTH LOSS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
3/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
21.8%
12/55 • Number of events 19 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
ASTHENIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
CHEST PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
CHILLS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
FATIGUE
|
50.0%
6/12 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
42.9%
3/7 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
55.6%
5/9 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
40.0%
22/55 • Number of events 34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
47.1%
16/34 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
INFUSION SITE SWELLING
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
MALAISE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
General disorders
NODULE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
SPEECH DISORDER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
IRRITABILITY
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Psychiatric disorders
STRESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
BLADDER TRABECULATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC SINUSITIS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Reproductive system and breast disorders
GENITAL RASH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Reproductive system and breast disorders
OEDEMA GENITAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
APHONIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.0%
3/12 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
32.7%
18/55 • Number of events 27 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
38.2%
13/34 • Number of events 19 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
30.9%
17/55 • Number of events 23 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
16.7%
2/12 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM PERFORATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
10.9%
6/55 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Respiratory, thoracic and mediastinal disorders
YAWNING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
BLOOD BLISTER
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
23.6%
13/55 • Number of events 15 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
10.9%
6/55 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
MACULE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
17.6%
6/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
16.7%
2/12 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
55.6%
5/9 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
27.3%
15/55 • Number of events 40 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
35.3%
12/34 • Number of events 35 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SCAB
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Skin and subcutaneous tissue disorders
STASIS DERMATITIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Social circumstances
PHYSICAL ASSAULT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 21 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 15 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
HYPOTENSION
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
8.8%
3/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD CREATININE INCREASED
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BLOOD URINE PRESENT
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
BODY TEMPERATURE FLUCTUATION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
10.9%
6/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
17.6%
6/34 • Number of events 12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.7%
7/55 • Number of events 53 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 14 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
STAPHYLOCOCCUS TEST POSITIVE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
VITAMIN D DECREASED
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
WEIGHT DECREASED
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
28.6%
2/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.5%
8/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
44.4%
4/9 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.5%
8/55 • Number of events 11 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
ENZYME ABNORMALITY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
8.3%
1/12 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
33.3%
4/12 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
29.1%
16/55 • Number of events 22 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.0%
11/55 • Number of events 19 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
25.0%
3/12 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
4/12 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
16.4%
9/55 • Number of events 12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
18.2%
10/55 • Number of events 12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
8.3%
1/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
21.8%
12/55 • Number of events 18 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 10 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
17.6%
6/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
17.6%
6/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.7%
5/34 • Number of events 8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
25.0%
2/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
DIZZINESS
|
33.3%
4/12 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
22.2%
2/9 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.0%
11/55 • Number of events 16 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
7.3%
4/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
HEAD DISCOMFORT
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
HEADACHE
|
16.7%
2/12 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
33.3%
3/9 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
37.5%
3/8 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 4 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.8%
4/34 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
3.6%
2/55 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PARAESTHESIA
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
9.1%
5/55 • Number of events 5 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.9%
2/34 • Number of events 2 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/55 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 6 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/34 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PERIPHERAL SENSORIMOTOR NEUROPATHY
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
5.5%
3/55 • Number of events 3 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
8.3%
1/12 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
14.3%
1/7 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
12.5%
1/8 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.0%
11/55 • Number of events 20 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
20.6%
7/34 • Number of events 14 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/12 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/7 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/9 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
11.1%
1/9 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
0.00%
0/8 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
1.8%
1/55 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
2.9%
1/34 • Number of events 1 • All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months.
Adverse Events Time Frame: From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 1. Institution/Investigator will not publish without Sponsor prior review and approval 2. Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.
- Publication restrictions are in place
Restriction type: OTHER