NCT01822886 · ADVERSE EVENTS

Adverse events

Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients · Source last updated 2019-10-14

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Romidepsin, Gemcitabine Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.	4 / 20	20 / 20	10 / 20

Group identifiers: EG000: Romidepsin, Gemcitabine

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
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever with shiver, Hypotension, Desaturation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Pneumothorax
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever, loss of consciousness and urinary infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever and pulmonary insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Ischaemic encephalopaty

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 (19.0)
stats
group Id
EG000
num Affected
12
num At Risk
20
num Events
12
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
11
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
16
num At Risk
20
num Events
16
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
10
num At Risk
20
num Events
10
term
Nausea and vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
20
num Events
6
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Transaminases increase

Complete source fields

event Groups

deaths Num Affected
10
deaths Num At Risk
20
description
Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
4
serious Num At Risk
20
title
Romidepsin, Gemcitabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
12
num At Risk
20
num Events
12
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
11
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
16
num At Risk
20
num Events
16
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
10
num At Risk
20
num Events
10
term
Nausea and vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
20
num Events
6
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Transaminases increase

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever with shiver, Hypotension, Desaturation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Pneumothorax
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever, loss of consciousness and urinary infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever and pulmonary insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Ischaemic encephalopaty

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Preserved source evidence · Not medical advice