NCT04697628 · ADVERSE EVENTS

Adverse events

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer · Source last updated 2026-02-24

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: For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)
Other-event reporting threshold: 5%

Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tisotumab Vedotin Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	82 / 250	233 / 250	123 / 253
Chemotherapy Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.	94 / 239	223 / 239	140 / 249

Group identifiers: EG000: Tisotumab Vedotin · EG001: Chemotherapy

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
250
num Events
2
group Id
EG001
num Affected
10
num At Risk
239
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
8
num At Risk
239
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
250
num Events
2
group Id
EG001
num Affected
4
num At Risk
239
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
4
num At Risk
239
num Events
4
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
2
num At Risk
239
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Vertigo

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
56
num At Risk
250
num Events
69
group Id
EG001
num Affected
119
num At Risk
239
num Events
160
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
250
num Events
3
group Id
EG001
num Affected
16
num At Risk
239
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
15
num At Risk
250
num Events
18
group Id
EG001
num Affected
52
num At Risk
239
num Events
119
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
33
num At Risk
250
num Events
41
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
39
num At Risk
250
num Events
53
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
30
num At Risk
250
num Events
36
group Id
EG001
num Affected
21
num At Risk
239
num Events
25
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
10
num At Risk
250
num Events
10
group Id
EG001
num Affected
12
num At Risk
239
num Events
15
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
59
num At Risk
250
num Events
68
group Id
EG001
num Affected
39
num At Risk
239
num Events
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
53
num At Risk
250
num Events
72
group Id
EG001
num Affected
36
num At Risk
239
num Events
45
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
83
num At Risk
250
num Events
101
group Id
EG001
num Affected
93
num At Risk
239
num Events
140
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
42
num At Risk
250
num Events
56
group Id
EG001
num Affected
43
num At Risk
239
num Events
61
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
40
num At Risk
250
num Events
49
group Id
EG001
num Affected
38
num At Risk
239
num Events
52
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
123
deaths Num At Risk
253
description
Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
id
EG000
other Num Affected
233
other Num At Risk
250
serious Num Affected
82
serious Num At Risk
250
title
Tisotumab Vedotin
deaths Num Affected
140
deaths Num At Risk
249
description
Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
id
EG001
other Num Affected
223
other Num At Risk
239
serious Num Affected
94
serious Num At Risk
239
title
Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
56
num At Risk
250
num Events
69
group Id
EG001
num Affected
119
num At Risk
239
num Events
160
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
250
num Events
3
group Id
EG001
num Affected
16
num At Risk
239
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
15
num At Risk
250
num Events
18
group Id
EG001
num Affected
52
num At Risk
239
num Events
119
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
33
num At Risk
250
num Events
41
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
39
num At Risk
250
num Events
53
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
30
num At Risk
250
num Events
36
group Id
EG001
num Affected
21
num At Risk
239
num Events
25
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
10
num At Risk
250
num Events
10
group Id
EG001
num Affected
12
num At Risk
239
num Events
15
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
59
num At Risk
250
num Events
68
group Id
EG001
num Affected
39
num At Risk
239
num Events
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
53
num At Risk
250
num Events
72
group Id
EG001
num Affected
36
num At Risk
239
num Events
45
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
83
num At Risk
250
num Events
101
group Id
EG001
num Affected
93
num At Risk
239
num Events
140
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
42
num At Risk
250
num Events
56
group Id
EG001
num Affected
43
num At Risk
239
num Events
61
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
40
num At Risk
250
num Events
49
group Id
EG001
num Affected
38
num At Risk
239
num Events
52
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
250
num Events
2
group Id
EG001
num Affected
10
num At Risk
239
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
8
num At Risk
239
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
250
num Events
2
group Id
EG001
num Affected
4
num At Risk
239
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
4
num At Risk
239
num Events
4
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
2
num At Risk
239
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
250
num Events
0
group Id
EG001
num Affected
1
num At Risk
239
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
250
num Events
1
group Id
EG001
num Affected
0
num At Risk
239
num Events
0
term
Vertigo

time Frame

For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)

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