NCT01908426 · ADVERSE EVENTS

Adverse events

Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib · Source last updated 2021-05-06

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 61 weeks
Other-event reporting threshold: 5%

The safety data includes subjects who were randomized and treated. Of 707 patients, 470 were randomized to received cabozantinib and 237 to placebo. Three subjects in the cabozantinib arm were randomized but did not receive study drug. Thus, a total of 704 subjects received study treatment in the Safety Population (467 cabozantinib, 237 placebo).

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	232 / 467	445 / 467	314 / 467
Placebo Oral cabozantinib-matched placebo tablet once daily Placebo tablets	87 / 237	173 / 237	167 / 237

Group identifiers: EG000: Cabozantinib (XL184) · EG001: Placebo

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
4
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Febrile neutropenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Leukopenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Lymphopenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
5
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Acute 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
467
group Id
EG001
num Affected
0
num At Risk
237
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Hypothyroidisim
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Retinal vein thrombosis

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 (17.0)
stats
group Id
EG000
num Affected
51
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
38
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
251
num At Risk
467
group Id
EG001
num Affected
43
num At Risk
237
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
47
num At Risk
467
group Id
EG001
num Affected
7
num At Risk
237
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
147
num At Risk
467
group Id
EG001
num Affected
41
num At Risk
237
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
63
num At Risk
467
group Id
EG001
num Affected
5
num At Risk
237
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
118
num At Risk
467
group Id
EG001
num Affected
24
num At Risk
237
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
99
num At Risk
467
group Id
EG001
num Affected
17
num At Risk
237
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
209
num At Risk
467
group Id
EG001
num Affected
70
num At Risk
237
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
65
num At Risk
467
group Id
EG001
num Affected
5
num At Risk
237
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
79
num At Risk
467
group Id
EG001
num Affected
13
num At Risk
237
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
103
num At Risk
467
group Id
EG001
num Affected
27
num At Risk
237
term
Aspartate aminotransferase increased

Complete source fields

description

event Groups

deaths Num Affected
314
deaths Num At Risk
467
description
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
id
EG000
other Num Affected
445
other Num At Risk
467
serious Num Affected
232
serious Num At Risk
467
title
Cabozantinib (XL184)
deaths Num Affected
167
deaths Num At Risk
237
description
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
id
EG001
other Num Affected
173
other Num At Risk
237
serious Num Affected
87
serious Num At Risk
237
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
51
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
38
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
251
num At Risk
467
group Id
EG001
num Affected
43
num At Risk
237
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
47
num At Risk
467
group Id
EG001
num Affected
7
num At Risk
237
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
147
num At Risk
467
group Id
EG001
num Affected
41
num At Risk
237
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
63
num At Risk
467
group Id
EG001
num Affected
5
num At Risk
237
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
118
num At Risk
467
group Id
EG001
num Affected
24
num At Risk
237
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
99
num At Risk
467
group Id
EG001
num Affected
17
num At Risk
237
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
209
num At Risk
467
group Id
EG001
num Affected
70
num At Risk
237
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
65
num At Risk
467
group Id
EG001
num Affected
5
num At Risk
237
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
79
num At Risk
467
group Id
EG001
num Affected
13
num At Risk
237
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
103
num At Risk
467
group Id
EG001
num Affected
27
num At Risk
237
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
4
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Febrile neutropenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Leukopenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Lymphopenia
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
5
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Acute 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
467
group Id
EG001
num Affected
0
num At Risk
237
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
467
group Id
EG001
num Affected
0
num At Risk
237
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
467
group Id
EG001
num Affected
1
num At Risk
237
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Hypothyroidisim
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
467
group Id
EG001
num Affected
0
num At Risk
237
term
Retinal vein thrombosis

time Frame

Up to 61 weeks

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

Preserved source evidence · Not medical advice