NCT03755791 · ADVERSE EVENTS

Adverse events

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy · Source last updated 2025-12-11

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 39 months
Other-event reporting threshold: 5%

Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Experimental Arm: Cabozantinib + Atezolizumab Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.	226 / 429	414 / 429	307 / 429
Single-Agent Cabozantinib Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.	88 / 188	182 / 188	135 / 188
Control Arm: Sorafenib Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.	85 / 207	202 / 207	141 / 207

Group identifiers: EG000: Experimental Arm: Cabozantinib + Atezolizumab · EG001: Single-Agent Cabozantinib · EG002: Control Arm: Sorafenib

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 v23.0
stats
group Id
EG000
num Affected
6
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
4
num At Risk
207
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiogenic shock

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 v23.0
stats
group Id
EG000
num Affected
55
num At Risk
429
group Id
EG001
num Affected
23
num At Risk
188
group Id
EG002
num Affected
24
num At Risk
207
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
37
num At Risk
429
group Id
EG001
num Affected
16
num At Risk
188
group Id
EG002
num Affected
7
num At Risk
207
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
43
num At Risk
429
group Id
EG001
num Affected
22
num At Risk
188
group Id
EG002
num Affected
11
num At Risk
207
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
93
num At Risk
429
group Id
EG001
num Affected
36
num At Risk
188
group Id
EG002
num Affected
9
num At Risk
207
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
68
num At Risk
429
group Id
EG001
num Affected
25
num At Risk
188
group Id
EG002
num Affected
38
num At Risk
207
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
35
num At Risk
429
group Id
EG001
num Affected
20
num At Risk
188
group Id
EG002
num Affected
17
num At Risk
207
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
54
num At Risk
429
group Id
EG001
num Affected
24
num At Risk
188
group Id
EG002
num Affected
14
num At Risk
207
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
65
num At Risk
429
group Id
EG001
num Affected
33
num At Risk
188
group Id
EG002
num Affected
23
num At Risk
207
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
215
num At Risk
429
group Id
EG001
num Affected
102
num At Risk
188
group Id
EG002
num Affected
98
num At Risk
207
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
429
group Id
EG001
num Affected
14
num At Risk
188
group Id
EG002
num Affected
6
num At Risk
207
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
13
num At Risk
429
group Id
EG001
num Affected
10
num At Risk
188
group Id
EG002
num Affected
4
num At Risk
207
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
70
num At Risk
429
group Id
EG001
num Affected
40
num At Risk
188
group Id
EG002
num Affected
30
num At Risk
207
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
307
deaths Num At Risk
429
description
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
id
EG000
other Num Affected
414
other Num At Risk
429
serious Num Affected
226
serious Num At Risk
429
title
Experimental Arm: Cabozantinib + Atezolizumab
deaths Num Affected
135
deaths Num At Risk
188
description
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
id
EG001
other Num Affected
182
other Num At Risk
188
serious Num Affected
88
serious Num At Risk
188
title
Single-Agent Cabozantinib
deaths Num Affected
141
deaths Num At Risk
207
description
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
id
EG002
other Num Affected
202
other Num At Risk
207
serious Num Affected
85
serious Num At Risk
207
title
Control Arm: Sorafenib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
55
num At Risk
429
group Id
EG001
num Affected
23
num At Risk
188
group Id
EG002
num Affected
24
num At Risk
207
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
37
num At Risk
429
group Id
EG001
num Affected
16
num At Risk
188
group Id
EG002
num Affected
7
num At Risk
207
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
43
num At Risk
429
group Id
EG001
num Affected
22
num At Risk
188
group Id
EG002
num Affected
11
num At Risk
207
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
93
num At Risk
429
group Id
EG001
num Affected
36
num At Risk
188
group Id
EG002
num Affected
9
num At Risk
207
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
68
num At Risk
429
group Id
EG001
num Affected
25
num At Risk
188
group Id
EG002
num Affected
38
num At Risk
207
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
35
num At Risk
429
group Id
EG001
num Affected
20
num At Risk
188
group Id
EG002
num Affected
17
num At Risk
207
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
54
num At Risk
429
group Id
EG001
num Affected
24
num At Risk
188
group Id
EG002
num Affected
14
num At Risk
207
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
65
num At Risk
429
group Id
EG001
num Affected
33
num At Risk
188
group Id
EG002
num Affected
23
num At Risk
207
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
215
num At Risk
429
group Id
EG001
num Affected
102
num At Risk
188
group Id
EG002
num Affected
98
num At Risk
207
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
24
num At Risk
429
group Id
EG001
num Affected
14
num At Risk
188
group Id
EG002
num Affected
6
num At Risk
207
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
13
num At Risk
429
group Id
EG001
num Affected
10
num At Risk
188
group Id
EG002
num Affected
4
num At Risk
207
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
70
num At Risk
429
group Id
EG001
num Affected
40
num At Risk
188
group Id
EG002
num Affected
30
num At Risk
207
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
6
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
4
num At Risk
207
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
0
num At Risk
188
group Id
EG002
num Affected
1
num At Risk
207
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
429
group Id
EG001
num Affected
1
num At Risk
188
group Id
EG002
num Affected
0
num At Risk
207
term
Cardiogenic shock

time Frame

Up to 39 months

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

Preserved source evidence · Not medical advice