NCT00426764 · ADVERSE EVENTS

Adverse events

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma · Source last updated 2020-02-11

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: Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days.
Other-event reporting threshold: 5%

NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Romidepsin Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	62 / 131	124 / 131	9 / 131

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 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
131
term
Anaemia haemolytic autoimmune
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
131
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
131
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Subendocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Angle closure glaucoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
131
term
Abdominal pain

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
32
num At Risk
131
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
131
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
37
num At Risk
131
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
53
num At Risk
131
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
13
num At Risk
131
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
131
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
9
num At Risk
131
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
39
num At Risk
131
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
46
num At Risk
131
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
12
num At Risk
131
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
76
num At Risk
131
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
14
num At Risk
131
term
Stomatitis

Complete source fields

description

event Groups

deaths Num Affected
9
deaths Num At Risk
131
description
Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
id
EG000
other Num Affected
124
other Num At Risk
131
serious Num Affected
62
serious Num At Risk
131
title
Romidepsin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
32
num At Risk
131
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
131
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
37
num At Risk
131
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
53
num At Risk
131
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
13
num At Risk
131
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
131
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
9
num At Risk
131
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
39
num At Risk
131
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
46
num At Risk
131
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
12
num At Risk
131
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
76
num At Risk
131
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
14
num At Risk
131
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
131
term
Anaemia haemolytic autoimmune
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
131
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
131
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
131
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Subendocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
131
term
Angle closure glaucoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
131
term
Abdominal pain

time Frame

Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days.

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