NCT01140347 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib · Source last updated 2015-12-28

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%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ramucirumab (IMC-1121B) + BSC Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.	124 / 277	254 / 277	Not reported / Not reported
Placebo + BSC Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.	92 / 276	235 / 276	Not reported / Not reported

Group identifiers: EG000: Ramucirumab (IMC-1121B) + BSC · EG001: Placebo + BSC

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 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
2
num At Risk
276
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
2
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
277
num Events
7
group Id
EG001
num Affected
9
num At Risk
276
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
8
num At Risk
277
num Events
8
group Id
EG001
num Affected
3
num At Risk
276
num Events
4
term
Ascites

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 16.1
stats
group Id
EG000
num Affected
29
num At Risk
277
num Events
54
group Id
EG001
num Affected
31
num At Risk
276
num Events
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
14
num At Risk
277
num Events
54
group Id
EG001
num Affected
7
num At Risk
276
num Events
19
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
16
num At Risk
277
num Events
80
group Id
EG001
num Affected
4
num At Risk
276
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
48
num At Risk
277
num Events
189
group Id
EG001
num Affected
12
num At Risk
276
num Events
26
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
19
num At Risk
277
num Events
27
group Id
EG001
num Affected
28
num At Risk
276
num Events
31
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
45
num At Risk
277
num Events
63
group Id
EG001
num Affected
58
num At Risk
276
num Events
86
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
26
num At Risk
277
num Events
34
group Id
EG001
num Affected
25
num At Risk
276
num Events
32
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
72
num At Risk
277
num Events
110
group Id
EG001
num Affected
40
num At Risk
276
num Events
47
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
36
num At Risk
277
num Events
39
group Id
EG001
num Affected
34
num At Risk
276
num Events
39
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
50
num At Risk
277
num Events
74
group Id
EG001
num Affected
38
num At Risk
276
num Events
52
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
18
num At Risk
277
num Events
22
group Id
EG001
num Affected
4
num At Risk
276
num Events
4
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
52
num At Risk
277
num Events
71
group Id
EG001
num Affected
52
num At Risk
276
num Events
74
term
Nausea

Complete source fields

event Groups

description
Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
id
EG000
other Num Affected
254
other Num At Risk
277
serious Num Affected
124
serious Num At Risk
277
title
Ramucirumab (IMC-1121B) + BSC
description
Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
id
EG001
other Num Affected
235
other Num At Risk
276
serious Num Affected
92
serious Num At Risk
276
title
Placebo + BSC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
29
num At Risk
277
num Events
54
group Id
EG001
num Affected
31
num At Risk
276
num Events
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
14
num At Risk
277
num Events
54
group Id
EG001
num Affected
7
num At Risk
276
num Events
19
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
16
num At Risk
277
num Events
80
group Id
EG001
num Affected
4
num At Risk
276
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
48
num At Risk
277
num Events
189
group Id
EG001
num Affected
12
num At Risk
276
num Events
26
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
19
num At Risk
277
num Events
27
group Id
EG001
num Affected
28
num At Risk
276
num Events
31
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
45
num At Risk
277
num Events
63
group Id
EG001
num Affected
58
num At Risk
276
num Events
86
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
26
num At Risk
277
num Events
34
group Id
EG001
num Affected
25
num At Risk
276
num Events
32
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
72
num At Risk
277
num Events
110
group Id
EG001
num Affected
40
num At Risk
276
num Events
47
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
36
num At Risk
277
num Events
39
group Id
EG001
num Affected
34
num At Risk
276
num Events
39
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
50
num At Risk
277
num Events
74
group Id
EG001
num Affected
38
num At Risk
276
num Events
52
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
18
num At Risk
277
num Events
22
group Id
EG001
num Affected
4
num At Risk
276
num Events
4
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
52
num At Risk
277
num Events
71
group Id
EG001
num Affected
52
num At Risk
276
num Events
74
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
2
num At Risk
276
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
277
num Events
2
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
277
num Events
7
group Id
EG001
num Affected
9
num At Risk
276
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
277
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
8
num At Risk
277
num Events
8
group Id
EG001
num Affected
3
num At Risk
276
num Events
4
term
Ascites

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