NCT03687125 · ADVERSE EVENTS

Adverse events

Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18

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: From first dose of tinostamustine up to end of study (up to 6 months)
Other-event reporting threshold: 0%

Safety population included all participants who received tinostamustine.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tinostamustine (180 mg/m^2) Participants received single dose of 180 mg/m\^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.	1 / 3	3 / 3	0 / 3
Tinostamustine (220 mg/m^2) Participants received single dose of 220 mg/m\^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.	2 / 3	3 / 3	0 / 3

Group identifiers: EG000: Tinostamustine (180 mg/m^2) · EG001: Tinostamustine (220 mg/m^2)

Serious 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
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Electrocardiogram QT prolonged
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Febrile neutropenia

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 (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Anal incontinence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Stomatitis

Complete source fields

description

Safety population included all participants who received tinostamustine.

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants received single dose of 180 mg/m\^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Tinostamustine (180 mg/m^2)
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received single dose of 220 mg/m\^2 tinostamustine IV injection on Day -1 followed by ASCT on Day 1.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Tinostamustine (220 mg/m^2)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Anal incontinence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
Stomatitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Electrocardiogram QT prolonged
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
term
Febrile neutropenia

time Frame

From first dose of tinostamustine up to end of study (up to 6 months)

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Preserved source evidence · Not medical advice