NCT01865747 · ADVERSE EVENTS

Adverse events

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma · Source last updated 2021-04-27

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: 08 August 2013 - 22 May 2015
Other-event reporting threshold: 5%

The safety data includes subjects who were randomized and treated. Of 658 patients, 330 were randomized to receive cabozantinib and 328 everolimus. Five subjects in the everolimus arm were randomized but not treated. One subject randomized to the everolimus arm received cabozantinib only as study treatment and was evaluated in the cabozantinib arm for the Safety population (331 cabozantinib, 322 everolimus).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cabozantinib (XL184) Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets	131 / 331	328 / 331	Not reported / Not reported
Everolimus (Afinitor) Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets	139 / 322	270 / 322	Not reported / Not reported

Group identifiers: EG000: Cabozantinib (XL184) · EG001: Everolimus (Afinitor)

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 (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Abdominal lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
6
num At Risk
331
num Events
6
group Id
EG001
num Affected
12
num At Risk
322
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
331
num Events
2
group Id
EG001
num Affected
3
num At Risk
322
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Palpitations

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
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
68
num At Risk
331
num Events
68
group Id
EG001
num Affected
2
num At Risk
322
num Events
2
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
50
num At Risk
331
num Events
50
group Id
EG001
num Affected
30
num At Risk
322
num Events
30
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
26
num At Risk
331
num Events
26
group Id
EG001
num Affected
7
num At Risk
322
num Events
7
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
83
num At Risk
331
num Events
83
group Id
EG001
num Affected
61
num At Risk
322
num Events
61
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
245
num At Risk
331
num Events
245
group Id
EG001
num Affected
88
num At Risk
322
num Events
88
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
40
num At Risk
331
num Events
40
group Id
EG001
num Affected
15
num At Risk
322
num Events
15
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
32
num At Risk
331
num Events
32
group Id
EG001
num Affected
6
num At Risk
322
num Events
6
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
164
num At Risk
331
num Events
164
group Id
EG001
num Affected
89
num At Risk
322
num Events
89
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
105
num At Risk
331
num Events
105
group Id
EG001
num Affected
44
num At Risk
322
num Events
44
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
185
num At Risk
331
num Events
185
group Id
EG001
num Affected
149
num At Risk
322
num Events
149
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
53
num At Risk
331
num Events
53
group Id
EG001
num Affected
19
num At Risk
322
num Events
19
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
58
num At Risk
331
num Events
58
group Id
EG001
num Affected
18
num At Risk
322
num Events
18
term
Aspartate Aminotransferase Increased

Complete source fields

description

event Groups

description
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
id
EG000
other Num Affected
328
other Num At Risk
331
serious Num Affected
131
serious Num At Risk
331
title
Cabozantinib (XL184)
description
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
id
EG001
other Num Affected
270
other Num At Risk
322
serious Num Affected
139
serious Num At Risk
322
title
Everolimus (Afinitor)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
68
num At Risk
331
num Events
68
group Id
EG001
num Affected
2
num At Risk
322
num Events
2
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
50
num At Risk
331
num Events
50
group Id
EG001
num Affected
30
num At Risk
322
num Events
30
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
26
num At Risk
331
num Events
26
group Id
EG001
num Affected
7
num At Risk
322
num Events
7
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
83
num At Risk
331
num Events
83
group Id
EG001
num Affected
61
num At Risk
322
num Events
61
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
245
num At Risk
331
num Events
245
group Id
EG001
num Affected
88
num At Risk
322
num Events
88
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
40
num At Risk
331
num Events
40
group Id
EG001
num Affected
15
num At Risk
322
num Events
15
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
32
num At Risk
331
num Events
32
group Id
EG001
num Affected
6
num At Risk
322
num Events
6
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
164
num At Risk
331
num Events
164
group Id
EG001
num Affected
89
num At Risk
322
num Events
89
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
105
num At Risk
331
num Events
105
group Id
EG001
num Affected
44
num At Risk
322
num Events
44
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
185
num At Risk
331
num Events
185
group Id
EG001
num Affected
149
num At Risk
322
num Events
149
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
53
num At Risk
331
num Events
53
group Id
EG001
num Affected
19
num At Risk
322
num Events
19
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
58
num At Risk
331
num Events
58
group Id
EG001
num Affected
18
num At Risk
322
num Events
18
term
Aspartate Aminotransferase Increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Abdominal lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
6
num At Risk
331
num Events
6
group Id
EG001
num Affected
12
num At Risk
322
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
331
num Events
2
group Id
EG001
num Affected
3
num At Risk
322
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
331
num Events
0
group Id
EG001
num Affected
1
num At Risk
322
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
331
num Events
1
group Id
EG001
num Affected
0
num At Risk
322
num Events
0
term
Palpitations

time Frame

08 August 2013 - 22 May 2015

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

Preserved source evidence · Not medical advice