Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
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 20.0 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 treated safety run-in participants
Groups in this outcome
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.
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
Safety Run-in: Increased TLS Risk at Baseline
15
Safety Run-in: Low TLS Risk at Baseline
6
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run-in: Increased TLS Risk at Baseline
15
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
6
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
Safety Run-in: Increased TLS Risk at Baseline
15
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
5
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
Safety Run-in: Increased TLS Risk at Baseline
14
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
6
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
Safety Run-in: Increased TLS Risk at Baseline
13
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
4
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
Safety Run-in: Increased TLS Risk at Baseline
13
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
5
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
Safety Run-in: Increased TLS Risk at Baseline
12
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
4
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
Safety Run-in: Increased TLS Risk at Baseline
6
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
2
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
Safety Run-in: Increased TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
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
Safety Run-in: Increased TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
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
Safety Run-in: Increased TLS Risk at Baseline
4
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
2
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
Safety Run-in: Increased TLS Risk at Baseline
7
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
4
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
Safety Run-in: Increased TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
3
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
Safety Run-in: Increased TLS Risk at Baseline
3
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
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
Safety Run-in: Increased TLS Risk at Baseline
3
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
1
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
Safety Run-in: Increased TLS Risk at Baseline
14
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
4
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
Safety Run-in: Increased TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
1
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
Safety Run-in: Increased TLS Risk at Baseline
0
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
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
Safety Run-in: Increased TLS Risk at Baseline
13
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
3
Not reported
Not reported
Not reported
Not reported
Any TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run-in: Increased TLS Risk at Baseline
14
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
3
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
Safety Run-in: Increased TLS Risk at Baseline
14
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
2
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
Safety Run-in: Increased TLS Risk at Baseline
9
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
1
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
Safety Run-in: Increased TLS Risk at Baseline
10
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
1
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
Safety Run-in: Increased TLS Risk at Baseline
10
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run-in: Increased TLS Risk at Baseline
1
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
Not reported
Not reported
Not reported
Not reported
Major Hemorrhage
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run-in: Increased TLS Risk at Baseline
2
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
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
Safety Run-in: Increased TLS Risk at Baseline
2
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
Not reported
Not reported
Not reported
Not reported
Major Hemorrhage, TESAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run-in: Increased TLS Risk at Baseline
2
Not reported
Not reported
Not reported
Not reported
Safety Run-in: Low TLS Risk at Baseline
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
6
title
Any TEAE
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
5
title
Any TEAE, Grade 3
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
6
title
Any Venetoclax (V) Related TEAE
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
4
title
Any V Related TEAE Grade >=3
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
5
title
Any Ibrutinib (I) Related TEAE
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
4
title
Any I Related TEAE Grade >=3
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
title
Any TEAE Leading to Discontinuation of Study Drug (I or V)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Any TEAE Leading to Discontinuation of Study Drug (I only)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Any TEAE Leading to Discontinuation of Study Drug (V only)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
title
Any TEAE Leading to Discontinuation of Study Drug (Both I and V)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
4
title
Any TEAE Leading to Dose Reduction of Study Drug (I or V)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
title
Any TEAE Leading to Dose Reduction of Study Drug (I Only)
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
6
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 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.
id
OG000
title
Safety Run-in: Increased TLS Risk at Baseline
description
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.
id
OG001
title
Safety Run-in: Low TLS Risk at Baseline
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated safety run-in 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 20.0 months
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)
Triangle