Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22
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 the first dose of investigational product (IP) up to 28 days after the last dose of IP up to the data cutoff date of 01 September 2017; median treatment duration in Part 1 Expansion was 5.2 months (range 0.5 to 32.8 months).
What was measured
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: • Resulted in death; • Was life threatening; • Required inpatient hospitalization or prolongation of existing hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly/birth defect; • Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Analysis population: All participants in Phase 1 Expansion who received at least 1 dose of study treatment.
Groups in this outcome
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
Participants ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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 Dose Expansion Arm 1: Enasidenib 100 mg QD
49
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
25
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
25
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
27
Reported measurements
Any Treatment-emergent Adverse Event (TEAE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
49
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
24
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
25
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
27
Not reported
Not reported
Not reported
Not reported
TEAE Related to Investigational Product (IP)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
43
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
18
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
22
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
23
Not reported
Not reported
Not reported
Not reported
Grade 3-4 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
47
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
21
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
21
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
20
Not reported
Not reported
Not reported
Not reported
Grade 3-4 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
20
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
9
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
15
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
7
Not reported
Not reported
Not reported
Not reported
Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
8
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
2
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
8
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
6
Not reported
Not reported
Not reported
Not reported
Grade 5 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
1
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
41
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
19
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
20
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
17
Not reported
Not reported
Not reported
Not reported
Serious TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
7
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
6
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
8
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
2
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Discontinuation (D/C) of IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
6
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
2
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
8
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
4
Not reported
Not reported
Not reported
Not reported
TEAE Related to IP Leading to D/C of IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
2
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
2
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
1
Not reported
Not reported
Not reported
Not reported
TEAE Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
1
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
3
Not reported
Not reported
Not reported
Not reported
TEAE Related to IP Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
0
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
3
Not reported
Not reported
Not reported
Not reported
TEAE Leading to IP Interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
24
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
10
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
16
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
9
Not reported
Not reported
Not reported
Not reported
TEAE Related to IP Leading to Interruption of IP
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
9
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
3
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
7
Not reported
Not reported
Not reported
Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
49
group Id
OG001
value
24
group Id
OG002
value
25
group Id
OG003
value
27
title
Any Treatment-emergent Adverse Event (TEAE)
categories
measurements
group Id
OG000
value
43
group Id
OG001
value
18
group Id
OG002
value
22
group Id
OG003
value
23
title
TEAE Related to Investigational Product (IP)
categories
measurements
group Id
OG000
value
47
group Id
OG001
value
21
group Id
OG002
value
21
group Id
OG003
value
20
title
Grade 3-4 TEAE
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
9
group Id
OG002
value
15
group Id
OG003
value
7
title
Grade 3-4 TEAE Related to IP
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
6
title
Grade 5 TEAE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Grade 5 TEAE Related to IP
categories
measurements
group Id
OG000
value
41
group Id
OG001
value
19
group Id
OG002
value
20
group Id
OG003
value
17
title
Serious TEAE
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
6
group Id
OG002
value
8
group Id
OG003
value
2
title
Serious TEAE Related to IP
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
4
title
TEAE Leading to Discontinuation (D/C) of IP
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
1
title
TEAE Related to IP Leading to D/C of IP
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
title
TEAE Leading to Reduction of IP
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
title
TEAE Related to IP Leading to Reduction of IP
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
25
group Id
OG002
value
25
group Id
OG003
value
27
units
Participants
description
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: • Resulted in death; • Was life threatening; • Required inpatient hospitalization or prolongation of existing hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly/birth defect; • Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
groups
description
Participants ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG000
title
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
description
Participants \< 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG001
title
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
description
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG002
title
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
description
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG003
title
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants in Phase 1 Expansion who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From the first dose of investigational product (IP) up to 28 days after the last dose of IP up to the data cutoff date of 01 September 2017; median treatment duration in Part 1 Expansion was 5.2 months (range 0.5 to 32.8 months).
title
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Triangle