NCT02232516 · ADVERSE EVENTS

Adverse events

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma · Source last updated 2026-06-12

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: The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Romidepsin, Lenalidomide) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies	23 / 29	29 / 29	15 / 29

Group identifiers: EG000: Treatment (Romidepsin, Lenalidomide)

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
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
29
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Fatigue

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
stats
group Id
EG000
num Affected
26
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
8
num At Risk
29
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ear and labyrinth disorders - Other, specify

Complete source fields

event Groups

deaths Num Affected
15
deaths Num At Risk
29
description
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
29
other Num At Risk
29
serious Num Affected
23
serious Num At Risk
29
title
Treatment (Romidepsin, Lenalidomide)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
26
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
8
num At Risk
29
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Ear and labyrinth disorders - Other, specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
29
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
29
term
Fatigue

time Frame

The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment

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Preserved source evidence · Not medical advice