NCT02001623 · ADVERSE EVENTS

Adverse events

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-12-29

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: Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Other-event reporting threshold: 5%

Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation Part: 0.3 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.	2 / 3	3 / 3	2 / 3
Dose Escalation Part: 0.6 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.	1 / 3	3 / 3	1 / 3
Dose Escalation Part: 0.9 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.	0 / 3	3 / 3	0 / 3
Dose Escalation Part: 1.2 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.	2 / 3	3 / 3	0 / 3
Dose Escalation Part: 1.5 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.	2 / 3	3 / 3	0 / 3
Dose Escalation Part: 1.8 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.	2 / 3	3 / 3	0 / 3
Dose Escalation Part: 2.0 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	2 / 3	3 / 3	0 / 3
Dose Escalation Part: 2.2 mg/kg Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.	4 / 6	6 / 6	0 / 6
Dose Expansion Part: Bladder Cancer Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	7 / 15	15 / 15	0 / 15
Dose Expansion Part: Cervical Cancer Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	26 / 55	55 / 55	2 / 55
Dose Expansion Part: Endometrial Cancer Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	5 / 14	14 / 14	0 / 14
Dose Expansion Part: Esophageal Cancer Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	8 / 15	15 / 15	1 / 15
Dose Expansion Part: Non-Small-Cell Lung Cancer Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	6 / 15	15 / 15	1 / 15
Dose Expansion Part: Ovarian Cancer Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	13 / 36	36 / 36	2 / 36
Dose Expansion Part: Prostate Cancer Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.	6 / 18	18 / 18	1 / 18

Group identifiers: EG000: Dose Escalation Part: 0.3 mg/kg · EG001: Dose Escalation Part: 0.6 mg/kg · EG002: Dose Escalation Part: 0.9 mg/kg · EG003: Dose Escalation Part: 1.2 mg/kg · EG004: Dose Escalation Part: 1.5 mg/kg · EG005: Dose Escalation Part: 1.8 mg/kg · EG006: Dose Escalation Part: 2.0 mg/kg · EG007: Dose Escalation Part: 2.2 mg/kg · EG008: Dose Expansion Part: Bladder Cancer · EG009: Dose Expansion Part: Cervical Cancer · EG010: Dose Expansion Part: Endometrial Cancer · EG011: Dose Expansion Part: Esophageal Cancer · EG012: Dose Expansion Part: Non-Small-Cell Lung Cancer · EG013: Dose Expansion Part: Ovarian Cancer · EG014: Dose Expansion Part: Prostate Cancer

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
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
4
num At Risk
55
num Events
4
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
1
num At Risk
55
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
1
num At Risk
55
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
15
num Events
1
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Gastrointestinal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Oesophageal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Subileus

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
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Bile duct obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Ear congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
15
num Events
1
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Bradycardia

Complete source fields

description

Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Part: 0.3 mg/kg
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Escalation Part: 0.6 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Escalation Part: 0.9 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Part: 1.2 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Part: 1.5 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Part: 1.8 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Part: 2.0 mg/kg
deaths Num Affected
0
deaths Num At Risk
6
description
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
id
EG007
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Dose Escalation Part: 2.2 mg/kg
deaths Num Affected
0
deaths Num At Risk
15
description
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
id
EG008
other Num Affected
15
other Num At Risk
15
serious Num Affected
7
serious Num At Risk
15
title
Dose Expansion Part: Bladder Cancer
deaths Num Affected
2
deaths Num At Risk
55
description
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
id
EG009
other Num Affected
55
other Num At Risk
55
serious Num Affected
26
serious Num At Risk
55
title
Dose Expansion Part: Cervical Cancer
deaths Num Affected
0
deaths Num At Risk
14
description
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
id
EG010
other Num Affected
14
other Num At Risk
14
serious Num Affected
5
serious Num At Risk
14
title
Dose Expansion Part: Endometrial Cancer
deaths Num Affected
1
deaths Num At Risk
15
description
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
id
EG011
other Num Affected
15
other Num At Risk
15
serious Num Affected
8
serious Num At Risk
15
title
Dose Expansion Part: Esophageal Cancer

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Bile duct obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Ear congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
15
num Events
1
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
6
num Events
1
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
4
num At Risk
55
num Events
4
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
6
num Events
2
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
1
num At Risk
55
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
1
num At Risk
55
num Events
1
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
2
num At Risk
15
num Events
2
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
1
num At Risk
15
num Events
1
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
2
num At Risk
55
num Events
2
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
1
num At Risk
14
num Events
1
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Gastrointestinal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
1
num At Risk
15
num Events
1
term
Oesophageal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
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
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
6
num Events
0
group Id
EG008
num Affected
0
num At Risk
15
num Events
0
group Id
EG009
num Affected
0
num At Risk
55
num Events
0
group Id
EG010
num Affected
0
num At Risk
14
num Events
0
group Id
EG011
num Affected
0
num At Risk
15
num Events
0
term
Subileus

time Frame

Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.

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Preserved source evidence · Not medical advice