NCT00106431 · ADVERSE EVENTS

Adverse events

A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) · Source last updated 2019-10-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Treatment emergent events were collected from first dose to last visit which occurred approximately 1 month after the last dose. Patients were to be treated for 6 cycles (approximately 6 months) or until progression.
Other-event reporting threshold: 5%

Patients could remain on treatment after 6 months if they experienced a response to treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Romidepsin Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.	23 / 102	99 / 102	Not reported / Not reported

Group identifiers: EG000: Romidepsin

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Anaemia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
2
num At Risk
102
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Atrioventricular Block First Degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Atrioventricular Block Second Degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiac Failure NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiopulmonary Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiac Tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Supraventricular Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Ventricular Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Constipation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
57
num At Risk
102
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
35
num At Risk
102
term
Vomiting NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
20
num At Risk
102
term
Diarrhoea NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
12
num At Risk
102
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
7
num At Risk
102
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
6
num At Risk
102
term
Abdominal Pain NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
34
num At Risk
102
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
20
num At Risk
102
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
14
num At Risk
102
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
8
num At Risk
102
term
Oedema Peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
6
num At Risk
102
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
5
num At Risk
102
term
Rigors

Complete source fields

description

Patients could remain on treatment after 6 months if they experienced a response to treatment.

event Groups

description
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
id
EG000
other Num Affected
99
other Num At Risk
102
serious Num Affected
23
serious Num At Risk
102
title
Romidepsin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
57
num At Risk
102
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
35
num At Risk
102
term
Vomiting NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
20
num At Risk
102
term
Diarrhoea NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
12
num At Risk
102
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
7
num At Risk
102
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
6
num At Risk
102
term
Abdominal Pain NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
34
num At Risk
102
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
20
num At Risk
102
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
14
num At Risk
102
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
8
num At Risk
102
term
Oedema Peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
6
num At Risk
102
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
5
num At Risk
102
term
Rigors

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Anaemia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
2
num At Risk
102
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Atrioventricular Block First Degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Atrioventricular Block Second Degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiac Failure NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiopulmonary Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Cardiac Tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Supraventricular Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Ventricular Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6.0
stats
group Id
EG000
num Affected
1
num At Risk
102
term
Constipation

time Frame

Treatment emergent events were collected from first dose to last visit which occurred approximately 1 month after the last dose. Patients were to be treated for 6 cycles (approximately 6 months) or until progression.

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Preserved source evidence · Not medical advice