NCT02552121 · ADVERSE EVENTS

Adverse events

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-04-08

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: Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).	1 / 3	3 / 3	0 / 3
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).	2 / 6	6 / 6	0 / 6
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).	9 / 11	10 / 11	1 / 11
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).	2 / 3	3 / 3	0 / 3
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).	0 / 1	1 / 1	0 / 1
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).	2 / 5	5 / 5	0 / 5
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.	0 / 1	0 / 1	0 / 1
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.	1 / 3	3 / 3	0 / 3

Group identifiers: EG000: Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg · EG001: Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg · EG002: Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian · EG003: Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical · EG004: Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian · EG005: Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical · EG006: Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian · EG007: Part 2: Cohort Expansion: Cohort 6 1q3w Cervical

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
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
11
num Events
4
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Symblepharon
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Colonic pseudo-obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
General physical health deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
11
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
4
num At Risk
6
num Events
5
group Id
EG002
num Affected
5
num At Risk
11
num Events
5
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
2
num At Risk
5
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
5
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
4
num At Risk
11
num Events
4
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
3
num At Risk
5
num Events
4
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
3
group Id
EG002
num Affected
3
num At Risk
11
num Events
4
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
4
num At Risk
5
num Events
6
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Tongue blistering
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Abdominal discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain lower
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Haematochezia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
deaths Num Affected
0
deaths Num At Risk
6
description
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
deaths Num Affected
1
deaths Num At Risk
11
description
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
id
EG002
other Num Affected
10
other Num At Risk
11
serious Num Affected
9
serious Num At Risk
11
title
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
deaths Num Affected
0
deaths Num At Risk
1
description
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
deaths Num Affected
0
deaths Num At Risk
5
description
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
id
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
deaths Num Affected
0
deaths Num At Risk
1
description
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
id
EG006
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
4
num At Risk
6
num Events
5
group Id
EG002
num Affected
5
num At Risk
11
num Events
5
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
2
num At Risk
5
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
5
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
4
num At Risk
11
num Events
4
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
3
num At Risk
5
num Events
4
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
3
group Id
EG002
num Affected
3
num At Risk
11
num Events
4
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
4
num At Risk
5
num Events
6
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Tongue blistering
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
11
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Abdominal discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain lower
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Haematochezia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
11
num Events
4
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Symblepharon
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Colonic pseudo-obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
General physical health deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
11
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain

time Frame

Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice