NCT01774344 · ADVERSE EVENTS

Adverse events

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma · Source last updated 2020-08-20

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: Adverse event data were collected after start of study drug administration until 30 days after end of study treatment over a period of approximately three years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Description: Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care(BSC).	92 / 193	162 / 193	176 / 193
Regorafenib (Stivarga, BAY73-4506) Description: Subjects received regorafenib 160 mg (4 \*40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.	194 / 374	366 / 374	324 / 374

Group identifiers: EG000: Placebo · EG001: Regorafenib (Stivarga, BAY73-4506)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
3
group Id
EG001
num Affected
4
num At Risk
374
num Events
9
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
7
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
4
num At Risk
374
num Events
4
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
2
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
1
term
Retinal artery occlusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Abdominal discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
4
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Abdominal pain lower

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
193
num Events
40
group Id
EG001
num Affected
57
num At Risk
374
num Events
114
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
29
num At Risk
374
num Events
33
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
13
group Id
EG001
num Affected
20
num At Risk
374
num Events
24
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
18
num At Risk
193
num Events
22
group Id
EG001
num Affected
52
num At Risk
374
num Events
85
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
29
num At Risk
193
num Events
43
group Id
EG001
num Affected
85
num At Risk
374
num Events
127
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
57
group Id
EG001
num Affected
61
num At Risk
374
num Events
91
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
193
num Events
24
group Id
EG001
num Affected
67
num At Risk
374
num Events
79
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
44
group Id
EG001
num Affected
163
num At Risk
374
num Events
348
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
15
group Id
EG001
num Affected
22
num At Risk
374
num Events
24
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
26
num At Risk
193
num Events
38
group Id
EG001
num Affected
72
num At Risk
374
num Events
106
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
4
group Id
EG001
num Affected
31
num At Risk
374
num Events
44
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
13
num At Risk
193
num Events
17
group Id
EG001
num Affected
50
num At Risk
374
num Events
73
term
Vomiting

Complete source fields

event Groups

deaths Num Affected
176
deaths Num At Risk
193
description
Description: Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care(BSC).
id
EG000
other Num Affected
162
other Num At Risk
193
serious Num Affected
92
serious Num At Risk
193
title
Placebo
deaths Num Affected
324
deaths Num At Risk
374
description
Description: Subjects received regorafenib 160 mg (4 \*40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
id
EG001
other Num Affected
366
other Num At Risk
374
serious Num Affected
194
serious Num At Risk
374
title
Regorafenib (Stivarga, BAY73-4506)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
193
num Events
40
group Id
EG001
num Affected
57
num At Risk
374
num Events
114
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
29
num At Risk
374
num Events
33
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
13
group Id
EG001
num Affected
20
num At Risk
374
num Events
24
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
18
num At Risk
193
num Events
22
group Id
EG001
num Affected
52
num At Risk
374
num Events
85
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
29
num At Risk
193
num Events
43
group Id
EG001
num Affected
85
num At Risk
374
num Events
127
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
57
group Id
EG001
num Affected
61
num At Risk
374
num Events
91
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
193
num Events
24
group Id
EG001
num Affected
67
num At Risk
374
num Events
79
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
44
group Id
EG001
num Affected
163
num At Risk
374
num Events
348
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
15
group Id
EG001
num Affected
22
num At Risk
374
num Events
24
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
26
num At Risk
193
num Events
38
group Id
EG001
num Affected
72
num At Risk
374
num Events
106
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
4
group Id
EG001
num Affected
31
num At Risk
374
num Events
44
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
13
num At Risk
193
num Events
17
group Id
EG001
num Affected
50
num At Risk
374
num Events
73
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
3
group Id
EG001
num Affected
4
num At Risk
374
num Events
9
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
7
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
4
num At Risk
374
num Events
4
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
2
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
374
num Events
1
term
Retinal artery occlusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Abdominal discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
374
num Events
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
4
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
2
num At Risk
374
num Events
3
term
Abdominal pain lower

time Frame

Adverse event data were collected after start of study drug administration until 30 days after end of study treatment over a period of approximately three years

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Preserved source evidence · Not medical advice