Trial Outcomes & Findings for Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) (NCT NCT03112174)
NCT ID: NCT03112174
Last Updated: 2025-07-22
Results Overview
TLS events are defined as follows: * Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions: * For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine \> 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS. * In participants with renal dysfunction at baseline (CrCl \< 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death. * Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
366 participants
Primary outcome timeframe
After at least 3 months of treatment, with an overall median treatment duration of 20.0 months
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Safety Run-in: Increased TLS Risk at Baseline
Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Safety Run-in: Low TLS Risk at Baseline
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) once daily over a 5-week period for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
134
|
133
|
78
|
|
Overall Study
On Study Treatment at Study Closure
|
0
|
2
|
31
|
21
|
26
|
|
Overall Study
Off Treatment and On Study Follow Up at Study Closure
|
2
|
0
|
22
|
25
|
25
|
|
Overall Study
COMPLETED
|
2
|
2
|
53
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
81
|
87
|
27
|
Reasons for withdrawal
| Measure |
Safety Run-in: Increased TLS Risk at Baseline
Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Safety Run-in: Low TLS Risk at Baseline
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) once daily over a 5-week period for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
11
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
3
|
2
|
|
Overall Study
Death
|
8
|
3
|
67
|
73
|
18
|
|
Overall Study
Other, Not Specified
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
Baseline characteristics by cohort
| Measure |
Safety Run-in: Increased TLS Risk at Baseline
n=15 Participants
Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Safety Run-in: Low TLS Risk at Baseline
n=6 Participants
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
108 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
258 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
89 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
108 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
277 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
72 Participants
n=31 Participants
|
310 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
39 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
68 Participants
n=31 Participants
|
317 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: After at least 3 months of treatment, with an overall median treatment duration of 20.0 monthsPopulation: All treated safety run-in participants
TLS events are defined as follows: * Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions: * For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine \> 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS. * In participants with renal dysfunction at baseline (CrCl \< 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death. * Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in)
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: After at least 3 months of treatment, with an overall median treatment duration of 20.0 monthsPopulation: All treated safety run-in participants
DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications: Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting \>5 days; Gr 3 fatigue persisting \>7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug \>7 days for toxicity. Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC \<500/mm\^3) lasting for \> 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (\<25,000/mm\^3) that persists for \> 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug \>7 days for hematologic toxicity.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Any TEAE/Any Grade
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Any TEAE/ Grade 3+4
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Any TEAE/Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Atrial fibrillation/Any Grade
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Atrial fibrillation/Grade 3+4
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Atrial fibrillation/Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Infection/Any Grade
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Infection/Grade 3+4
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Infection/Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Neutropenia/Any Grade
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Neutropenia/Grade 3+4
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
Neutropenia/Grade 5
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 monthsPopulation: All treated safety run-in participants
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE
|
15 Participants
|
6 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE, Grade 3
|
15 Participants
|
5 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any Venetoclax (V) Related TEAE
|
14 Participants
|
6 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any V Related TEAE Grade >=3
|
13 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any Ibrutinib (I) Related TEAE
|
13 Participants
|
5 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any I Related TEAE Grade >=3
|
12 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Discontinuation of Study Drug (I or V)
|
6 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Discontinuation of Study Drug (I only)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Discontinuation of Study Drug (V only)
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Discontinuation of Study Drug (Both I and V)
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Reduction of Study Drug (I or V)
|
7 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Reduction of Study Drug (I Only)
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Reduction of Study Drug (V Only)
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Reduction of Study Drug (Both I and V)
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Hold of Study Drug (I or V)
|
14 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Hold of Study Drug (I Only)
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Hold of Study Drug (V Only)
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TEAE Leading to Dose Hold of Study Drug (Both I and V)
|
13 Participants
|
3 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TESAE
|
14 Participants
|
3 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TESAE, Grade >=3
|
14 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TESAE, V Related
|
9 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TESAE, I Related
|
10 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Any TESAE, V or I Related
|
10 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Fatal TEAE
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Major Hemorrhage
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Major Hemorrhage, Grade >=3
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Major Hemorrhage, TESAE
|
2 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: For an overall median time on study of 61.34 monthsPopulation: All randomized participants
PFS is defined as the time from the date of randomization to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Progression-free Survival (PFS) (Randomization Phase)
|
31.9 months
Interval 22.8 to 54.5
|
22.1 months
Interval 16.5 to 29.5
|
—
|
PRIMARY outcome
Timeframe: For an overall median time on study of 40.51 monthsPopulation: All Enrolled Treatment-Naïve Participants
CR rate is defined as the percentage of participants with a CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=78 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Complete Response (CR) Rate (Treatment-Naive Arm)
|
69.2 percentage of participants
Interval 57.8 to 79.2
|
—
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 74.78 monthsPopulation: All Enrolled Safety Run-in participants
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Overall Survival (OS) (Safety Run-in)
|
52.3 months
Interval 14.1 to
Not estimable due to small number of events.
|
NA months
Interval 1.5 to
Not estimable due to small number of events.
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 74.78 monthsPopulation: All Enrolled Safety Run-in participants
PFS is defined as the time from the date of the first dose of study treatment to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Progression-free Survival (PFS) (Safety Run-in)
|
46.9 months
Interval 13.0 to
Not estimable due to the small number of events.
|
35.0 months
Interval 1.2 to
Not estimable due to the small number of events.
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 74.78 monthsPopulation: All Enrolled Safety Run-in Subjects Achieving Response (Partial Response or Better)
DOR is defined for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=12 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=5 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Duration of Response (DOR) (Safety Run-in)
|
44.1 months
Interval 12.5 to
Not estimable due to the small number of events.
|
NA months
Interval 26.5 to
Not estimable due to the small number of events.
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 74.78 monthsPopulation: All enrolled Safety Run-in participants
ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=15 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=6 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Overall Response Rate (ORR) (Safety Run-in)
|
80.0 percentage of participants
Interval 51.9 to 95.7
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 monthsPopulation: All randomized participants
Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Percentage of Participants With a Complete Response (CR) (Randomization Phase)
|
53.7 percentage of participants
Interval 44.9 to 62.4
|
32.3 percentage of participants
Interval 24.5 to 41.0
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)Population: All randomized participants and all treatment-naive open-label arm participants.
ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Overall Response Rate (ORR) (Randomization Phase and Treatment-Naive Arm)
|
82.1 percentage of participants
Interval 74.5 to 88.2
|
74.4 percentage of participants
Interval 66.2 to 81.6
|
94.9 percentage of participants
Interval 87.4 to 98.6
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)Population: All enrolled treatment-naïve participants achieving CR who were evaluable for MRD (those who had positive MRD status at screening). Participants with a given post-screening sample.
MRD-negative remission rate is defined as the percentage of participants with undetectable MRD at documented CR in participants who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=31 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=8 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=34 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm)
Bone marrow aspirate
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
59.1 percentage of participants
Interval 36.4 to 79.3
|
|
MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm)
Peripheral blood
|
77.4 percentage of participants
Interval 58.9 to 90.4
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
76.5 percentage of participants
Interval 58.8 to 89.3
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)Population: All randomized and all enrolled treatment-naïve participants
OS is defined as the time from the date of randomization (Randomization Phase) or the first dose of study treatment (Treatment-Naïve arm) to death from any cause.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Overall Survival (OS) (Randomization Phase and Treatment-Naive Arm)
|
44.9 months
Interval 31.9 to
Not estimable due to the small number of events.
|
38.6 months
Interval 25.2 to 52.6
|
NA months
Interval 44.2 to
Not estimable due to the small number of events.
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)Population: All randomized participants and all enrolled treatment-naïve participants achieving response (partial response or better)
DOR is defined as the time frame for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=110 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=99 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=74 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Duration of Response (DOR) (Randomization Phase and Treatment-Naive Arm)
|
42.1 months
Interval 28.7 to
Not estimable due to the small number of events.
|
27.6 months
Interval 19.4 to 39.5
|
37.1 months
Interval 30.3 to
Not estimable due to the small number of events.
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)Population: All randomized and all enrolled treatment-naïve participants
TTNT is defined as the duration from the date of randomization (Randomization Phase) or date of first dose of study treatment (Treatment-Naive Arm) to the start date of any anti-lymphoma treatment subsequent to study treatment. Post-treatment stem cell transplantation, chimeric antigen receptor (CAR) T-cell therapy, or other cellular therapies were not considered subsequent anti-cancer treatments for participants responding to the study treatment (CR or PR).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 Participants
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Time to Next Treatment (TTNT) (Randomization Phase and Treatment-Naive Arm)
|
NA months
Interval 48.0 to
Not estimable due to the small number of events
|
35.4 months
Interval 24.7 to 49.8
|
NA months
Not estimable due to the small number of events
|
SECONDARY outcome
Timeframe: From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 19.5 monthsPopulation: All randomized and treated participants
AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=132 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE
|
134 Participants
|
131 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE, Grade 3
|
113 Participants
|
100 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any Venetoclax (V) Related TEAE
|
112 Participants
|
104 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any V Related TEAE Grade >=3
|
75 Participants
|
46 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any Ibrutinib (I) Related TEAE
|
121 Participants
|
114 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any I Related TEAE Grade >=3
|
83 Participants
|
58 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Discontinuation of Study Drug (I or V)
|
43 Participants
|
48 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Discontinuation of Study Drug (I only)
|
15 Participants
|
11 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Discontinuation of Study Drug (V only)
|
2 Participants
|
7 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Discontinuation of Study Drug (Both I and V)
|
26 Participants
|
30 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Reduction of Study Drug (I or V)
|
50 Participants
|
29 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Reduction of Study Drug (I Only)
|
19 Participants
|
14 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Reduction of Study Drug (V Only)
|
13 Participants
|
7 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Reduction of Study Drug (Both I and V)
|
18 Participants
|
8 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Hold of Study Drug (I or V)
|
106 Participants
|
99 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Hold of Study Drug (I Only)
|
18 Participants
|
18 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Hold of Study Drug (V Only)
|
6 Participants
|
4 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TEAE Leading to Dose Hold of Study Drug (Both I and V)
|
82 Participants
|
77 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TESAE
|
88 Participants
|
80 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TESAE, Grade >=3
|
76 Participants
|
73 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TESAE, V Related
|
31 Participants
|
25 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TESAE, I Related
|
47 Participants
|
37 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Any TESAE, V or I Related
|
49 Participants
|
37 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Fatal TEAE
|
22 Participants
|
18 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Major Hemorrhage
|
13 Participants
|
8 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Major Hemorrhage, Grade >=3
|
10 Participants
|
7 Participants
|
—
|
|
Number of Participants With TEAEs (Randomization Phase)
Major Hemorrhage, TESAE
|
12 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 monthsPopulation: All randomized and treated participants
Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=132 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Number of Participants With TLS TEAEs (Randomization Phase)
Any Grade
|
7 Participants
|
3 Participants
|
—
|
|
Number of Participants With TLS TEAEs (Randomization Phase)
Grades 3 and 4
|
6 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=106 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=108 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State Pharmacokinetics (PK) of Ibrutinib: Maximum Observed Plasma Concentration (Cmax) (Randomization Phase)
|
195 ng/mL
Standard Deviation 179
|
287 ng/mL
Standard Deviation 230
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=106 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=108 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Time to Cmax (Tmax) (Randomization Phase)
|
2.00 hours
Interval 0.0 to 8.0
|
2.00 hours
Interval 0.75 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=106 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) (Randomization Phase)
|
1090 ng·h/mL
Standard Deviation 870
|
1440 ng·h/mL
Standard Deviation 1060
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=65 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=73 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Terminal Elimination Half-Life (t1/2,Term) (Randomization Phase)
|
6.29 hours
Standard Deviation 1.92
|
6.66 hours
Standard Deviation 2.15
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=106 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Time of Last Measurable Concentration (Tlast) (Randomization Phase)
|
24.0 hours
Interval 7.0 to 24.0
|
24.0 hours
Interval 24.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=106 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From 0-24 Hours (AUC0-24) (Randomization Phase)
|
1090 ng·h/mL
Standard Deviation 870
|
1440 ng·h/mL
Standard Deviation 1060
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=65 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=73 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Terminal Elimination Rate Constant (λz) (Randomization Phase)
|
0.123 1/hour
Standard Deviation 0.0556
|
0.114 1/hour
Standard Deviation 0.0332
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=106 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Ibrutinib: Apparent Total Clearance at Steady State (CLss/F) (Randomization Phase)
|
1020 L/hour
Standard Deviation 1130
|
709 L/hour
Standard Deviation 651
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants receiving venetoclax with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Venetoclax: Cmax (Randomization Phase)
|
3620 ng/mL
Standard Deviation 1650
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants receiving venetoclax with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=98 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Venetoclax: AUC0-24 (Randomization Phase)
|
65000 ng·h/mL
Standard Deviation 32900
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants receiving venetoclax with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=102 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Venetoclax: Time to Cmax (Tmax) (Randomization Phase)
|
6.00 hours
Interval 0.0 to 8.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dosePopulation: Participants receiving venetoclax with an evaluable PK assessment at given time point.
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=98 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Steady-State PK of Venetoclax: CLss/F (Randomization Phase)
|
8.09 L/hour
Standard Deviation 4.82
|
—
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 61.34 months (Randomization Phase)Population: All randomized participants
The FACT-Lym lymphoma-specific additional concerns subscale responses to all items are rated on a 5-point scale ranging from 0 "not at all" to 4 "very much". The lymphoma subscale includes 15 items and scores range from 0 to 60, with higher scores representing better functional status and well-being. A 5-point change in the Lym subscale was selected as a conservative estimate of clinically meaningful deterioration in lymphoma symptoms.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=134 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=133 Participants
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Time to Worsening in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale of the Health-related Quality of Life (Randomization Phase)
|
9.3 months
Interval 6.5 to 12.7
|
12.5 months
Interval 8.3 to 17.9
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 40.51 monthsPopulation: All Enrolled Treatment-Naïve Subjects Achieving CR
Duration of CR, defined for subjects who achieve CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014) as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=54 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Duration of CR (Treatment-Naive Arm)
|
37.1 months
Interval 34.0 to
Not estimable due to low number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: For an overall median time on study of 40.51 monthsPopulation: All enrolled treatment-naïve participants
PFS is defined as the time from the date of the first dose of study treatment to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Randomization Phase: Ibrutinb + Venetoclax
n=78 Participants
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|
|
Progression-free Survival (PFS) (Treatment-Naive Arm)
|
40.2 months
Interval 29.4 to
Not estimable due to low number of events.
|
—
|
—
|
Adverse Events
Safety Run-in: Increased TLS Risk at Baseline
Serious events: 15 serious events
Other events: 15 other events
Deaths: 8 deaths
Safety Run-in: Low TLS Risk at Baseline
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Randomization Phase: Ibrutinb + Venetoclax
Serious events: 92 serious events
Other events: 131 other events
Deaths: 70 deaths
Randomization Phase: Ibrutinib + Placebo
Serious events: 86 serious events
Other events: 127 other events
Deaths: 78 deaths
Treatment-naive Open-label Arm
Serious events: 48 serious events
Other events: 77 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Safety Run-in: Increased TLS Risk at Baseline
n=15 participants at risk
Participants with an increased risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Safety Run-in: Low TLS Risk at Baseline
n=6 participants at risk
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Randomization Phase: Ibrutinb + Venetoclax
n=134 participants at risk
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=132 participants at risk
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 participants at risk
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
CARDIAC FAILURE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
MITRAL VALVE DISEASE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
CATARACT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
UVEITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
ASTHENIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
CARDIAC DEATH
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
CHEST PAIN
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
DEATH
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
FATIGUE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
GAIT DISTURBANCE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
MALAISE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
PYREXIA
|
20.0%
3/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
SEROSITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Immune system disorders
ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
BRONCHITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CENTRAL NERVOUS SYSTEM INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CLOSTRIDIUM COLITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
DISSEMINATED CRYPTOCOCCOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
FUNGAL ABSCESS CENTRAL NERVOUS SYSTEM
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
INFECTION
|
6.7%
1/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
MEDIASTINITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PERIORBITAL CELLULITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.7%
17/134 • Number of events 26 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA CHLAMYDIAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA MORAXELLA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
SEPSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
WOUND SEPSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
FALL
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL NEOPLASM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN LUNG NEOPLASM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MANTLE CELL LYMPHOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.2%
15/134 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
13.6%
18/132 • Number of events 27 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MANTLE CELL LYMPHOMA RECURRENT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
BRADYKINESIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
DIZZINESS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SEIZURE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SPEECH DISORDER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
TREMOR
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
RENAL FAILURE
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
UPPER AIRWAY OBSTRUCTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD POLYP
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS VASCULITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Social circumstances
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
HYPERTENSION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
HYPOTENSION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
Other adverse events
| Measure |
Safety Run-in: Increased TLS Risk at Baseline
n=15 participants at risk
Participants with an increased risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Safety Run-in: Low TLS Risk at Baseline
n=6 participants at risk
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
|
Randomization Phase: Ibrutinb + Venetoclax
n=134 participants at risk
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Randomization Phase: Ibrutinib + Placebo
n=132 participants at risk
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
|
Treatment-naive Open-label Arm
n=78 participants at risk
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
10/15 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
83.3%
5/6 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
62.7%
84/134 • Number of events 243 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
36.4%
48/132 • Number of events 89 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
47.4%
37/78 • Number of events 196 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DRY MOUTH
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.6%
10/132 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DUODENITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.2%
19/134 • Number of events 28 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.3%
11/132 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
DYSPHAGIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ENTERITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
FAECES SOFT
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
FEMORAL HERNIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
FLATULENCE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.1%
11/78 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
5/15 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
83.3%
5/6 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
32.1%
43/134 • Number of events 78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.9%
21/132 • Number of events 36 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
30.8%
24/78 • Number of events 75 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
STOMATITIS
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.3%
11/132 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.4%
12/78 • Number of events 31 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
TONGUE ERYTHEMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
TONGUE HAEMORRHAGE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
5/15 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.1%
27/134 • Number of events 59 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.6%
14/132 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
23.1%
18/78 • Number of events 35 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
ADVERSE DRUG REACTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
ASTHENIA
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
19.4%
26/134 • Number of events 38 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
13.6%
18/132 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
CATHETER SITE BRUISE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
CHEST PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
CHILLS
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
EXTRAVASATION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
FATIGUE
|
33.3%
5/15 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
66.7%
4/6 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
29.1%
39/134 • Number of events 66 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
27.3%
36/132 • Number of events 77 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
38.5%
30/78 • Number of events 78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
IMPAIRED HEALING
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.5%
10/134 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
INJECTION SITE BRUISING
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
OEDEMA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
OEDEMA PERIPHERAL
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.9%
16/134 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.9%
21/132 • Number of events 28 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.9%
14/78 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
PERIPHERAL SWELLING
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.8%
9/132 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
PYREXIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.9%
28/134 • Number of events 51 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
21.2%
28/132 • Number of events 56 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.5%
16/78 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
HEPATITIS CHOLESTATIC
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Hepatobiliary disorders
PORTAL FIBROSIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Immune system disorders
ALLERGY TO ARTHROPOD BITE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.8%
9/132 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CANDIDA INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CONJUNCTIVITIS
|
6.7%
1/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.3%
11/132 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
COVID-19
|
13.3%
2/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.9%
16/134 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.1%
16/132 • Number of events 22 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
24.4%
19/78 • Number of events 22 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
DEMODICIDOSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PNEUMONIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
EPIDIDYMITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ERYSIPELAS
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
FOLLICULITIS
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
FUNGAL INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.1%
8/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
INFLUENZA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
NASAL ABSCESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.1%
8/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
RHINITIS
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.8%
9/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
SINUSITIS
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
SKIN CANDIDA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
TINEA CRURIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
20.0%
3/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.2%
23/134 • Number of events 42 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.6%
14/132 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
URINARY TRACT INFECTION
|
26.7%
4/15 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.4%
14/134 • Number of events 22 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.6%
10/132 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Infections and infestations
WOUND INFECTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
CONTUSION
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
FALL
|
26.7%
4/15 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SCRATCH
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD CREATININE INCREASED
|
20.0%
3/15 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.8%
13/132 • Number of events 27 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
BLOOD UREA INCREASED
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.8%
10/78 • Number of events 32 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
PLATELET COUNT DECREASED
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
TROPONIN T INCREASED
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
WEIGHT DECREASED
|
13.3%
2/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.2%
15/134 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.0%
3/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.9%
24/134 • Number of events 33 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.7%
9/134 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.3%
11/132 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
33.3%
5/15 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.7%
21/134 • Number of events 31 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.1%
8/132 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.5%
16/78 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
20.0%
3/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
66.7%
4/6 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.4%
14/134 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.5%
16/78 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
20.0%
3/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.4%
22/134 • Number of events 29 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.4%
23/132 • Number of events 47 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.4%
12/78 • Number of events 26 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.9%
14/78 • Number of events 26 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
24.2%
32/132 • Number of events 56 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.7%
13/134 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.9%
17/132 • Number of events 34 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.5%
16/78 • Number of events 34 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.1%
12/132 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
DIZZINESS
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.9%
16/134 • Number of events 22 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.2%
20/132 • Number of events 35 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
21.8%
17/78 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
DYSARTHRIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
DYSKINESIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
HEADACHE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.2%
15/134 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
22/132 • Number of events 43 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
19.2%
15/78 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
20.0%
3/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.6%
14/132 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
PARESIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
PRESYNCOPE
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SCIATICA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
TREMOR
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Nervous system disorders
VASCULAR ENCEPHALOPATHY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
ANXIETY
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
DISORIENTATION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.8%
13/132 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
BLADDER HYPERTROPHY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
HAEMATURIA
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.1%
11/78 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
POLLAKIURIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
RENAL FAILURE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Renal and urinary disorders
URINARY RETENTION
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
5/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.9%
28/134 • Number of events 46 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
26.5%
35/132 • Number of events 55 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
13/78 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
13.3%
2/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.7%
17/134 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 24 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.9%
14/78 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.7%
9/134 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.6%
14/132 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.4%
14/134 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 21 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
6.7%
1/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/132 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD POLYP
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
BLOOD BLISTER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
6.7%
1/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.7%
9/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.2%
15/134 • Number of events 18 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.4%
15/132 • Number of events 26 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.1%
11/78 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.0%
8/134 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
26.7%
4/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
13.4%
18/134 • Number of events 33 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.1%
12/132 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
13/78 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
HAEMATOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
HYPERTENSION
|
20.0%
3/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.9%
20/134 • Number of events 32 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.4%
23/132 • Number of events 28 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
19.2%
15/78 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Vascular disorders
HYPOTENSION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.2%
7/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
ANAEMIA
|
26.7%
4/15 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
20.1%
27/134 • Number of events 40 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.9%
17/132 • Number of events 32 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
21.8%
17/78 • Number of events 27 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
20.0%
3/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.6%
10/132 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
21.8%
17/78 • Number of events 25 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 53 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
46.7%
7/15 • Number of events 33 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
34.3%
46/134 • Number of events 207 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.4%
19/132 • Number of events 25 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
26/78 • Number of events 67 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.2%
3/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
26.7%
4/15 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
66.7%
4/6 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.4%
22/134 • Number of events 74 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.2%
20/132 • Number of events 46 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
12/134 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.1%
12/132 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.8%
10/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
BRADYCARDIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Ear and labyrinth disorders
EAR PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.76%
1/132 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
ASTIGMATISM
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
CATARACT
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.8%
9/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
DRY EYE
|
26.7%
4/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
13.4%
18/134 • Number of events 25 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.2%
20/132 • Number of events 45 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
EYE DISCHARGE
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
5/132 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.6%
2/78 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
EYE IRRITATION
|
13.3%
2/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.7%
13/134 • Number of events 16 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
15.9%
21/132 • Number of events 27 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.7%
6/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
EYE PAIN
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.3%
7/132 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
HYPERMETROPIA
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
LACRIMATION INCREASED
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
13.4%
18/134 • Number of events 30 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.1%
16/132 • Number of events 25 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
MACULAR DEGENERATION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
MACULOPATHY
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/78 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
OCULAR HYPERAEMIA
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.75%
1/134 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
PHOTOPHOBIA
|
20.0%
3/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
8.2%
11/134 • Number of events 14 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.1%
12/132 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.8%
3/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
PHOTOPSIA
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
2.3%
3/132 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
VISION BLURRED
|
26.7%
4/15 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
50.0%
3/6 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
18.7%
25/134 • Number of events 47 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.4%
23/132 • Number of events 50 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.3%
8/78 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
13.3%
2/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.9%
20/134 • Number of events 42 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
12.1%
16/132 • Number of events 32 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
11.5%
9/78 • Number of events 13 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Eye disorders
VITREOUS FLOATERS
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.7%
5/134 • Number of events 7 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
7.6%
10/132 • Number of events 12 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.7%
1/15 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/6 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/134 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
5.1%
4/78 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
13.3%
2/15 • Number of events 4 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
10.4%
14/134 • Number of events 22 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.1%
12/132 • Number of events 17 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.1%
11/78 • Number of events 20 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
13.3%
2/15 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
4.5%
6/134 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.8%
9/132 • Number of events 11 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
9.0%
7/78 • Number of events 8 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.5%
2/134 • Number of events 2 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
3.0%
4/132 • Number of events 9 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
6.4%
5/78 • Number of events 10 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.00%
0/15 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
1/6 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/134 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
0.00%
0/132 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
1.3%
1/78 • Number of events 1 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.0%
3/15 • Number of events 3 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
33.3%
2/6 • Number of events 5 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
14.2%
19/134 • Number of events 23 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
17.4%
23/132 • Number of events 59 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
16.7%
13/78 • Number of events 19 • For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
All treated participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER