Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin
A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks
What was measured
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
Analysis population: Safety population includes all participants who received at least one dose of romidepsin
Groups in this outcome
Phase 1: Romidepsin 9mg/m^2
Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
Phase 1: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
Phase 2: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
Total: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
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: Romidepsin 9mg/m^2
3
Phase 1: Romidepsin 14mg/m^2
7
Phase 2: Romidepsin 14mg/m^2
40
Total: Romidepsin 14mg/m^2
47
Reported measurements
Any 1 TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
40
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
47
Not reported
Not reported
Not reported
Not reported
TEAE related to any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
7
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
40
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
47
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 3 or greater
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
37
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
43
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE ≥Grade 3 related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
37
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
43
Not reported
Not reported
Not reported
Not reported
≥ 1 serious TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
10
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
14
Not reported
Not reported
Not reported
Not reported
Serious TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
6
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
10
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
10
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
13
Not reported
Not reported
Not reported
Not reported
TEAE related leading to discontinuation of drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
9
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
12
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose held of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
24
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
28
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to dose held of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
22
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
25
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose reduction of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
17
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
21
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to dose reduction of drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
17
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
21
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose interruption of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
4
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
23
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
27
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to dose interruption of drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
3
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
22
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
25
Not reported
Not reported
Not reported
Not reported
At least one TEAE with NCI CTCAE Grade 5
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Romidepsin 9mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Romidepsin 14mg/m^2
0
Not reported
Not reported
Not reported
Not reported
Phase 2: Romidepsin 14mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Total: Romidepsin 14mg/m^2
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
40
group Id
OG003
value
47
title
Any 1 TEAE
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
40
group Id
OG003
value
47
title
TEAE related to any study drug
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
37
group Id
OG003
value
43
title
TEAE with CTCAE Grade 3 or greater
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
37
group Id
OG003
value
43
title
TEAE with CTCAE ≥Grade 3 related to study drug
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
10
group Id
OG003
value
14
title
≥ 1 serious TEAE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
6
group Id
OG003
value
10
title
Serious TEAE related to study drug
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
10
group Id
OG003
value
13
title
TEAE leading to discontinuation of study drug
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
9
group Id
OG003
value
12
title
TEAE related leading to discontinuation of drug
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
24
group Id
OG003
value
28
title
TEAE leading to dose held of study drug
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
22
group Id
OG003
value
25
title
Related TEAE leading to dose held of study drug
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
17
group Id
OG003
value
21
title
TEAE leading to dose reduction of study drug
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
17
group Id
OG003
value
21
title
Related TEAE leading to dose reduction of drug
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
40
group Id
OG003
value
47
units
Participants
description
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
groups
description
Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
id
OG000
title
Phase 1: Romidepsin 9mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG001
title
Phase 1: Romidepsin 14mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG002
title
Phase 2: Romidepsin 14mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG003
title
Total: Romidepsin 14mg/m^2
param Type
NUMBER
population Description
Safety population includes all participants who received at least one dose of romidepsin
reporting Status
POSTED
time Frame
Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks
title
Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin
Triangle