NCT06469138 · ADVERSE EVENTS

Adverse events

A Study to Investigate 14C-bemcentinib in Healthy Male Subjects · Source last updated 2025-01-29

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: Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib This is the only treatment arm in this study. Up to 8 participants will receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study.	0 / 6	3 / 6	0 / 6

Group identifiers: EG000: Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib

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
notes
Headache
organ System
Nervous system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Vessel Puncture Site Bruise
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Bruising Right Antecubital Fossa (Venepuncture Related)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Loose Stool
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Vessel Puncture Site Bruise
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Bruising to Left Antecubital Fossa (Venepuncture Related)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID-19
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Oropharyngeal Pain
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Sore Throat
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Night Sweats
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Night Sweats

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
This is the only treatment arm in this study. Up to 8 participants will receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study.
id
EG000
other Num Affected
3
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Headache
organ System
Nervous system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Vessel Puncture Site Bruise
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Bruising Right Antecubital Fossa (Venepuncture Related)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Loose Stool
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Vessel Puncture Site Bruise
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Bruising to Left Antecubital Fossa (Venepuncture Related)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID-19
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Oropharyngeal Pain
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Sore Throat
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Night Sweats
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Night Sweats

time Frame

Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).

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Preserved source evidence · Not medical advice