NCT03547700 · ADVERSE EVENTS

Adverse events

Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) · Source last updated 2026-05-06

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: AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.	0 / 1	1 / 1	1 / 1
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15 Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.	3 / 9	9 / 9	3 / 9
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.	1 / 1	1 / 1	0 / 1

Group identifiers: EG000: Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 · EG001: Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15 · EG002: Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15

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
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
2
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FEVER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
HYPOTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
LUNG INFECTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
PLEURAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
SEPSIS
assessment Type
SYSTEMATIC_ASSESSMENT
notes
pulmonary embolus
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
CARDIAC DISORDERS - OTHER, SPECIFY

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
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ALANINE AMINOTRANSFERASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ALKALINE PHOSPHATASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ASPARTATE AMINOTRANSFERASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
CREATININE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
5
num At Risk
9
num Events
6
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
DIZZINESS
assessment Type
SYSTEMATIC_ASSESSMENT
notes
increased PSA
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
6
num At Risk
9
num Events
11
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
6
num At Risk
9
num Events
9
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
5
num At Risk
9
num Events
6
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
3
num At Risk
9
num Events
3
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ANOREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cervical lymphadenopathy
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
deaths Num Affected
3
deaths Num At Risk
9
description
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
id
EG001
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
deaths Num Affected
0
deaths Num At Risk
1
description
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
id
EG002
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ALANINE AMINOTRANSFERASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ALKALINE PHOSPHATASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ASPARTATE AMINOTRANSFERASE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
CREATININE INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
5
num At Risk
9
num Events
6
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
DIZZINESS
assessment Type
SYSTEMATIC_ASSESSMENT
notes
increased PSA
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
6
num At Risk
9
num Events
11
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
6
num At Risk
9
num Events
9
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
5
num At Risk
9
num Events
6
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
3
num At Risk
9
num Events
3
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
ANOREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cervical lymphadenopathy
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
2
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
FEVER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
HYPOTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
LUNG INFECTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
PLEURAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
term
SEPSIS
assessment Type
SYSTEMATIC_ASSESSMENT
notes
pulmonary embolus
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
term
CARDIAC DISORDERS - OTHER, SPECIFY

time Frame

AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.

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Preserved source evidence · Not medical advice