NCT01178411 · ADVERSE EVENTS

Adverse events

An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols · Source last updated 2021-03-10

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: Up to 3021 days
Other-event reporting threshold: 5%

All participants who received ≥1 dose of study drug are included.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tivantinib (Monotherapy or Combination) Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.	19 / 60	55 / 60	4 / 60

Group identifiers: EG000: Tivantinib (Monotherapy or Combination)

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 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abdominal mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
60
term
Disease progression

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 13.1
stats
group Id
EG000
num Affected
6
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
16
num At Risk
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
4
num At Risk
60
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
14
num At Risk
60
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
20
num At Risk
60
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
17
num At Risk
60
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Mucosal inflammation

Complete source fields

description

All participants who received ≥1 dose of study drug are included.

event Groups

deaths Num Affected
4
deaths Num At Risk
60
description
Participants received tivantinib 360 mg twice daily by mouth as monotherapy or combination therapy.
id
EG000
other Num Affected
55
other Num At Risk
60
serious Num Affected
19
serious Num At Risk
60
title
Tivantinib (Monotherapy or Combination)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
7
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
16
num At Risk
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
4
num At Risk
60
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
14
num At Risk
60
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
20
num At Risk
60
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
17
num At Risk
60
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
5
num At Risk
60
term
Mucosal inflammation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abdominal mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
60
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
60
term
Disease progression

time Frame

Up to 3021 days

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Preserved source evidence · Not medical advice