Number of Participants With TEAEs (Randomization Phase)
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 19.5 months
What was measured
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).
Analysis population: All randomized and treated participants
Groups in this outcome
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) 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Randomization Phase: Ibrutinb + Venetoclax
134
Randomization Phase: Ibrutinib + Placebo
132
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
134
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
131
Not reported
Not reported
Not reported
Not reported
Any TEAE, Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
113
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
100
Not reported
Not reported
Not reported
Not reported
Any Venetoclax (V) Related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
112
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
104
Not reported
Not reported
Not reported
Not reported
Any V Related TEAE Grade >=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
75
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
46
Not reported
Not reported
Not reported
Not reported
Any Ibrutinib (I) Related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
121
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
114
Not reported
Not reported
Not reported
Not reported
Any I Related TEAE Grade >=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
83
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
58
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Discontinuation of Study Drug (I or V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
43
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
48
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Discontinuation of Study Drug (I only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
15
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
11
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Discontinuation of Study Drug (V only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
2
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
7
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Discontinuation of Study Drug (Both I and V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
26
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
30
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Reduction of Study Drug (I or V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
50
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
29
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Reduction of Study Drug (I Only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
19
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
14
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Reduction of Study Drug (V Only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
13
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
7
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Reduction of Study Drug (Both I and V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
18
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
8
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Hold of Study Drug (I or V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
106
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
99
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Hold of Study Drug (I Only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
18
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
18
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Hold of Study Drug (V Only)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
6
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
4
Not reported
Not reported
Not reported
Not reported
Any TEAE Leading to Dose Hold of Study Drug (Both I and V)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
82
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
77
Not reported
Not reported
Not reported
Not reported
Any TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
88
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
80
Not reported
Not reported
Not reported
Not reported
Any TESAE, Grade >=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
76
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
73
Not reported
Not reported
Not reported
Not reported
Any TESAE, V Related
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
31
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
25
Not reported
Not reported
Not reported
Not reported
Any TESAE, I Related
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
47
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
37
Not reported
Not reported
Not reported
Not reported
Any TESAE, V or I Related
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
49
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
37
Not reported
Not reported
Not reported
Not reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
22
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
18
Not reported
Not reported
Not reported
Not reported
Major Hemorrhage
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
13
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
8
Not reported
Not reported
Not reported
Not reported
Major Hemorrhage, Grade >=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
10
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
7
Not reported
Not reported
Not reported
Not reported
Major Hemorrhage, TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Randomization Phase: Ibrutinb + Venetoclax
12
Not reported
Not reported
Not reported
Not reported
Randomization Phase: Ibrutinib + Placebo
6
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
134
group Id
OG001
value
131
title
Any TEAE
categories
measurements
group Id
OG000
value
113
group Id
OG001
value
100
title
Any TEAE, Grade 3
categories
measurements
group Id
OG000
value
112
group Id
OG001
value
104
title
Any Venetoclax (V) Related TEAE
categories
measurements
group Id
OG000
value
75
group Id
OG001
value
46
title
Any V Related TEAE Grade >=3
categories
measurements
group Id
OG000
value
121
group Id
OG001
value
114
title
Any Ibrutinib (I) Related TEAE
categories
measurements
group Id
OG000
value
83
group Id
OG001
value
58
title
Any I Related TEAE Grade >=3
categories
measurements
group Id
OG000
value
43
group Id
OG001
value
48
title
Any TEAE Leading to Discontinuation of Study Drug (I or V)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
11
title
Any TEAE Leading to Discontinuation of Study Drug (I only)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
7
title
Any TEAE Leading to Discontinuation of Study Drug (V only)
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
30
title
Any TEAE Leading to Discontinuation of Study Drug (Both I and V)
categories
measurements
group Id
OG000
value
50
group Id
OG001
value
29
title
Any TEAE Leading to Dose Reduction of Study Drug (I or V)
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
14
title
Any TEAE Leading to Dose Reduction of Study Drug (I Only)
denoms
counts
group Id
OG000
value
134
group Id
OG001
value
132
units
Participants
description
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).
groups
description
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.
id
OG000
title
Randomization Phase: Ibrutinb + Venetoclax
description
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.
id
OG001
title
Randomization Phase: Ibrutinib + Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized and treated participants
reporting Status
POSTED
time Frame
From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 19.5 months
title
Number of Participants With TEAEs (Randomization Phase)
Triangle