NCT01170663 · ADVERSE EVENTS

Adverse events

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma · Source last updated 2019-09-18

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%

One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ramucirumab and Paclitaxel 8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.	161 / 327	324 / 327	Not reported / Not reported
Placebo and Paclitaxel Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.	146 / 329	321 / 329	Not reported / Not reported

Group identifiers: EG000: Ramucirumab and Paclitaxel · EG001: Placebo and Paclitaxel

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 16.0
stats
group Id
EG000
num Affected
8
num At Risk
327
num Events
8
group Id
EG001
num Affected
7
num At Risk
329
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
8
num At Risk
327
num Events
8
group Id
EG001
num Affected
5
num At Risk
329
num Events
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
12
num At Risk
327
num Events
17
group Id
EG001
num Affected
4
num At Risk
329
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
3
num At Risk
327
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
2
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Extrasystoles

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 16.0
stats
group Id
EG000
num Affected
110
num At Risk
327
num Events
261
group Id
EG001
num Affected
116
num At Risk
329
num Events
274
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
111
num At Risk
327
num Events
471
group Id
EG001
num Affected
69
num At Risk
329
num Events
199
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
174
num At Risk
327
num Events
878
group Id
EG001
num Affected
102
num At Risk
329
num Events
247
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
43
num At Risk
327
num Events
103
group Id
EG001
num Affected
20
num At Risk
329
num Events
37
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
327
num Events
27
group Id
EG001
num Affected
20
num At Risk
329
num Events
25
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
98
num At Risk
327
num Events
165
group Id
EG001
num Affected
62
num At Risk
329
num Events
104
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
48
group Id
EG001
num Affected
35
num At Risk
329
num Events
52
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
46
group Id
EG001
num Affected
25
num At Risk
329
num Events
39
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
70
num At Risk
327
num Events
95
group Id
EG001
num Affected
71
num At Risk
329
num Events
89
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
105
num At Risk
327
num Events
250
group Id
EG001
num Affected
76
num At Risk
329
num Events
126
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
25
group Id
EG001
num Affected
17
num At Risk
329
num Events
18
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
114
num At Risk
327
num Events
236
group Id
EG001
num Affected
106
num At Risk
329
num Events
183
term
Nausea

Complete source fields

description

One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).

event Groups

description
8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
id
EG000
other Num Affected
324
other Num At Risk
327
serious Num Affected
161
serious Num At Risk
327
title
Ramucirumab and Paclitaxel
description
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
id
EG001
other Num Affected
321
other Num At Risk
329
serious Num Affected
146
serious Num At Risk
329
title
Placebo and Paclitaxel

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
110
num At Risk
327
num Events
261
group Id
EG001
num Affected
116
num At Risk
329
num Events
274
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
111
num At Risk
327
num Events
471
group Id
EG001
num Affected
69
num At Risk
329
num Events
199
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
174
num At Risk
327
num Events
878
group Id
EG001
num Affected
102
num At Risk
329
num Events
247
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
43
num At Risk
327
num Events
103
group Id
EG001
num Affected
20
num At Risk
329
num Events
37
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
327
num Events
27
group Id
EG001
num Affected
20
num At Risk
329
num Events
25
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
98
num At Risk
327
num Events
165
group Id
EG001
num Affected
62
num At Risk
329
num Events
104
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
48
group Id
EG001
num Affected
35
num At Risk
329
num Events
52
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
46
group Id
EG001
num Affected
25
num At Risk
329
num Events
39
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
70
num At Risk
327
num Events
95
group Id
EG001
num Affected
71
num At Risk
329
num Events
89
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
105
num At Risk
327
num Events
250
group Id
EG001
num Affected
76
num At Risk
329
num Events
126
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
25
group Id
EG001
num Affected
17
num At Risk
329
num Events
18
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
114
num At Risk
327
num Events
236
group Id
EG001
num Affected
106
num At Risk
329
num Events
183
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
8
num At Risk
327
num Events
8
group Id
EG001
num Affected
7
num At Risk
329
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
8
num At Risk
327
num Events
8
group Id
EG001
num Affected
5
num At Risk
329
num Events
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
12
num At Risk
327
num Events
17
group Id
EG001
num Affected
4
num At Risk
329
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
3
num At Risk
327
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
2
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Extrasystoles

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Preserved source evidence · Not medical advice