NCT00597116 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma · Source last updated 2016-10-10

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: Not reported
Other-event reporting threshold: 5%

The enrolled and randomised population was Vandetanib 14 \& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \& Vinorelbine 10)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vandetanib Vandetanib 300 mg/day oral	6 / 13	13 / 13	Not reported / Not reported
Vinorelbine Vinorelbine 30 mg/m2 iv, administrated weekly	3 / 10	10 / 10	Not reported / Not reported

Group identifiers: EG000: Vandetanib · EG001: Vinorelbine

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
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Venous stasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Acute Abdomen
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Gastrointestinal Haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Febrile Neutropoenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Inguinal Hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Deterioration Of General Health
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Pulmonary Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Papilloedema

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 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
10
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Ear Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
6
num At Risk
10
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Abdominal Distension

Complete source fields

description

event Groups

description
Vandetanib 300 mg/day oral
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Vandetanib
description
Vinorelbine 30 mg/m2 iv, administrated weekly
id
EG001
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
Vinorelbine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
10
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Ear Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
6
num At Risk
10
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
3
num At Risk
10
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Abdominal Distension

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Venous stasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Acute Abdomen
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Gastrointestinal Haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Febrile Neutropoenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Inguinal Hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
10
term
Deterioration Of General Health
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Pulmonary Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
10
term
Papilloedema

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice