Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia · Source last updated 2022-08-29
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 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator rated the severity of each AE according to the CTCAE Version 4.0 and the following:
Grade 1: The AE is transient and easily tolerated (mild).
Grade 2: The AE causes discomfort and interrupts usual activities (moderate).
Grade 3: The AE causes considerable interference with usual activities and may be incapacitating (moderate to severe).
Grade 4: The AE is life threatening requiring urgent intervention.
Grade 5: The AE resulted in death.
The investigator assessed each event as either having a reasonable possibility or no reasonable possibility of being related to the use of study drug.
Treatment-emergent events are defined as events that began or worsened in severity after the first dose of study drug.
Analysis population: All enrolled participants who received at least one dose of study drug
Groups in this outcome
Phase 1: 600 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
Phase 1: 800 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
Phase 2: 600 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
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
Phase 1: 600 mg Venetoclax + LDAC
8
Phase 1: 800 mg Venetoclax + LDAC
10
Phase 2: 600 mg Venetoclax + LDAC
74
Reported measurements
Any treatment-emergent adverse event (TEAE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
10
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
74
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 3 or 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
10
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
72
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 3 or above
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
10
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
72
Not reported
Not reported
Not reported
Not reported
Venetoclax-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
9
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
66
Not reported
Not reported
Not reported
Not reported
LDAC-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
9
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
71
Not reported
Not reported
Not reported
Not reported
TEAE leading to hospitalization
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
7
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
8
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
64
Not reported
Not reported
Not reported
Not reported
TEAE leading to venetoclax discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
3
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
5
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
24
Not reported
Not reported
Not reported
Not reported
TEAE leading to LDAC discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
3
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
5
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
26
Not reported
Not reported
Not reported
Not reported
TEAE leading to venetoclax interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
3
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
4
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
45
Not reported
Not reported
Not reported
Not reported
TEAE leading to LDAC interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
3
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
3
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
38
Not reported
Not reported
Not reported
Not reported
TEAE leading to venetoclax reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
0
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
1
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
6
Not reported
Not reported
Not reported
Not reported
TEAE leading to LDAC reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
0
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
0
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: 600 mg Venetoclax + LDAC
1
Not reported
Not reported
Not reported
Not reported
Phase 1: 800 mg Venetoclax + LDAC
4
Not reported
Not reported
Not reported
Not reported
Phase 2: 600 mg Venetoclax + LDAC
15
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
10
group Id
OG002
value
74
title
Any treatment-emergent adverse event (TEAE)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
10
group Id
OG002
value
72
title
TEAE with CTCAE Grade 3 or 4
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
10
group Id
OG002
value
72
title
TEAE with CTCAE Grade 3 or above
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
9
group Id
OG002
value
66
title
Venetoclax-related TEAE
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
9
group Id
OG002
value
71
title
LDAC-related TEAE
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
64
title
TEAE leading to hospitalization
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
24
title
TEAE leading to venetoclax discontinuation
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
26
title
TEAE leading to LDAC discontinuation
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
45
title
TEAE leading to venetoclax interruption
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
38
title
TEAE leading to LDAC interruption
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
6
title
TEAE leading to venetoclax reduction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
TEAE leading to LDAC reduction
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
10
group Id
OG002
value
74
units
Participants
description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator rated the severity of each AE according to the CTCAE Version 4.0 and the following:
Grade 1: The AE is transient and easily tolerated (mild).
Grade 2: The AE causes discomfort and interrupts usual activities (moderate).
Grade 3: The AE causes considerable interference with usual activities and may be incapacitating (moderate to severe).
Grade 4: The AE is life threatening requiring urgent intervention.
Grade 5: The AE resulted in death.
The investigator assessed each event as either having a reasonable possibility or no reasonable possibility of being related to the use of study drug.
Treatment-emergent events are defined as events that began or worsened in severity after the first dose of study drug.
groups
description
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
id
OG000
title
Phase 1: 600 mg Venetoclax + LDAC
description
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
id
OG001
title
Phase 1: 800 mg Venetoclax + LDAC
description
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
id
OG002
title
Phase 2: 600 mg Venetoclax + LDAC
param Type
COUNT_OF_PARTICIPANTS
population Description
All enrolled participants who received at least one dose of study drug
reporting Status
POSTED
time Frame
From first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Triangle