NCT03438396 · ADVERSE EVENTS

Adverse events

A Trial of Tisotumab Vedotin in Cervical Cancer · Source last updated 2023-07-25

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: From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tisotumab Vedotin Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.	44 / 101	99 / 101	86 / 101

Group identifiers: EG000: Tisotumab Vedotin

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
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
101
num Events
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
101
num Events
2
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
101
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Neutropenic sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
101
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
101
num Events
3
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Abdominal pain

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
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
41
num At Risk
101
num Events
51
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
25
num At Risk
101
num Events
29
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
20
num At Risk
101
num Events
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
17
num At Risk
101
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
13
num At Risk
101
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
8
num At Risk
101
num Events
8
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
101
num Events
6
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
35
num At Risk
101
num Events
47
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
18
num At Risk
101
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
15
num At Risk
101
num Events
38
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
7
num At Risk
101
num Events
7
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
8
num At Risk
101
num Events
9
term
Oedema peripheral

Complete source fields

event Groups

deaths Num Affected
86
deaths Num At Risk
101
description
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
id
EG000
other Num Affected
99
other Num At Risk
101
serious Num Affected
44
serious Num At Risk
101
title
Tisotumab Vedotin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
41
num At Risk
101
num Events
51
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
25
num At Risk
101
num Events
29
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
20
num At Risk
101
num Events
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
17
num At Risk
101
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
13
num At Risk
101
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
8
num At Risk
101
num Events
8
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
6
num At Risk
101
num Events
6
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
35
num At Risk
101
num Events
47
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
18
num At Risk
101
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
15
num At Risk
101
num Events
38
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
7
num At Risk
101
num Events
7
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
8
num At Risk
101
num Events
9
term
Oedema peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
4
num At Risk
101
num Events
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
101
num Events
2
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
101
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Neutropenic sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
3
num At Risk
101
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
2
num At Risk
101
num Events
3
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 22.1
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
term
Abdominal pain

time Frame

From Day 1 through 30 days after the last dose of study drug (approximately 49 months)

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Preserved source evidence · Not medical advice