NCT04362007 · ADVERSE EVENTS

Adverse events

A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma · Source last updated 2026-02-25

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: Approximately 52.6 months
Other-event reporting threshold: 5%

Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).	0 / 7	7 / 7	0 / 7
Cohort 2 ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2

Serious adverse events

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

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Gingivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Oral candidiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Otitis externa

Complete source fields

description

Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the start of open-label treatment.

event Groups

deaths Num Affected
0
deaths Num At Risk
7
description
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Cohort 1
deaths Num Affected
0
deaths Num At Risk
1
description
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Cohort 2

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Gingivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Oral candidiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Ver. 27.1
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
1
term
Otitis externa

time Frame

Approximately 52.6 months

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Preserved source evidence · Not medical advice