NCT00917384 · ADVERSE EVENTS

Adverse events

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma · Source last updated 2019-09-25

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
IMC-1121B (Ramucirumab) Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.	112 / 236	213 / 236	Not reported / Not reported
Placebo Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.	51 / 115	91 / 115	Not reported / Not reported

Group identifiers: EG000: IMC-1121B (Ramucirumab) · 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 15.1
stats
group Id
EG000
num Affected
11
num At Risk
236
num Events
11
group Id
EG001
num Affected
2
num At Risk
115
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
236
num Events
0
group Id
EG001
num Affected
2
num At Risk
115
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
2
num At Risk
115
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
236
num Events
0
group Id
EG001
num Affected
1
num At Risk
115
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
1
num At Risk
115
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
10
num At Risk
236
num Events
11
group Id
EG001
num Affected
3
num At Risk
115
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Abdominal pain upper

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 15.1
stats
group Id
EG000
num Affected
33
num At Risk
236
num Events
41
group Id
EG001
num Affected
16
num At Risk
115
num Events
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
40
num At Risk
236
num Events
53
group Id
EG001
num Affected
26
num At Risk
115
num Events
36
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
26
num At Risk
236
num Events
35
group Id
EG001
num Affected
5
num At Risk
115
num Events
5
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
18
num At Risk
236
num Events
23
group Id
EG001
num Affected
8
num At Risk
115
num Events
8
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
37
num At Risk
236
num Events
53
group Id
EG001
num Affected
24
num At Risk
115
num Events
38
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
35
num At Risk
236
num Events
64
group Id
EG001
num Affected
9
num At Risk
115
num Events
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
6
num At Risk
236
num Events
8
group Id
EG001
num Affected
7
num At Risk
115
num Events
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
23
num At Risk
236
num Events
33
group Id
EG001
num Affected
11
num At Risk
115
num Events
22
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
45
num At Risk
236
num Events
62
group Id
EG001
num Affected
30
num At Risk
115
num Events
44
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
45
num At Risk
236
num Events
70
group Id
EG001
num Affected
26
num At Risk
115
num Events
36
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
30
num At Risk
236
num Events
60
group Id
EG001
num Affected
16
num At Risk
115
num Events
19
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
58
num At Risk
236
num Events
90
group Id
EG001
num Affected
28
num At Risk
115
num Events
52
term
Fatigue

Complete source fields

event Groups

description
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
id
EG000
other Num Affected
213
other Num At Risk
236
serious Num Affected
112
serious Num At Risk
236
title
IMC-1121B (Ramucirumab)
description
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
id
EG001
other Num Affected
91
other Num At Risk
115
serious Num Affected
51
serious Num At Risk
115
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
33
num At Risk
236
num Events
41
group Id
EG001
num Affected
16
num At Risk
115
num Events
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
40
num At Risk
236
num Events
53
group Id
EG001
num Affected
26
num At Risk
115
num Events
36
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
26
num At Risk
236
num Events
35
group Id
EG001
num Affected
5
num At Risk
115
num Events
5
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
18
num At Risk
236
num Events
23
group Id
EG001
num Affected
8
num At Risk
115
num Events
8
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
37
num At Risk
236
num Events
53
group Id
EG001
num Affected
24
num At Risk
115
num Events
38
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
35
num At Risk
236
num Events
64
group Id
EG001
num Affected
9
num At Risk
115
num Events
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
6
num At Risk
236
num Events
8
group Id
EG001
num Affected
7
num At Risk
115
num Events
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
23
num At Risk
236
num Events
33
group Id
EG001
num Affected
11
num At Risk
115
num Events
22
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
45
num At Risk
236
num Events
62
group Id
EG001
num Affected
30
num At Risk
115
num Events
44
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
45
num At Risk
236
num Events
70
group Id
EG001
num Affected
26
num At Risk
115
num Events
36
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
30
num At Risk
236
num Events
60
group Id
EG001
num Affected
16
num At Risk
115
num Events
19
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
58
num At Risk
236
num Events
90
group Id
EG001
num Affected
28
num At Risk
115
num Events
52
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
11
num At Risk
236
num Events
11
group Id
EG001
num Affected
2
num At Risk
115
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
236
num Events
0
group Id
EG001
num Affected
2
num At Risk
115
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
2
num At Risk
115
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
236
num Events
0
group Id
EG001
num Affected
1
num At Risk
115
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
1
num At Risk
115
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
10
num At Risk
236
num Events
11
group Id
EG001
num Affected
3
num At Risk
115
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
236
num Events
1
group Id
EG001
num Affected
0
num At Risk
115
num Events
0
term
Abdominal pain upper

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

Preserved source evidence · Not medical advice