NCT01168973 · ADVERSE EVENTS

Adverse events

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · 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: Randomization through 30 days following last infusion (up to Cycle 38, 21 days/cycle).
Other-event reporting threshold: 5%

Safety Population: All randomized participants who received any quantity of study treatment, grouped by the treatment they actually received. Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ramucirumab and Docetaxel On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.	284 / 627	601 / 627	Not reported / Not reported
Placebo and Docetaxel On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.	281 / 618	583 / 618	Not reported / Not reported

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

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
10
num At Risk
627
num Events
16
group Id
EG001
num Affected
14
num At Risk
618
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
86
num At Risk
627
num Events
104
group Id
EG001
num Affected
51
num At Risk
618
num Events
56
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
5
num At Risk
627
num Events
6
group Id
EG001
num Affected
10
num At Risk
618
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
30
num At Risk
627
num Events
38
group Id
EG001
num Affected
27
num At Risk
618
num Events
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
3
num At Risk
627
num Events
3
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
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
627
num Events
0
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
627
num Events
6
group Id
EG001
num Affected
2
num At Risk
618
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
627
num Events
2
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
627
num Events
2
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
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
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Cardiac failure congestive

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
135
num At Risk
627
num Events
306
group Id
EG001
num Affected
174
num At Risk
618
num Events
399
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
79
num At Risk
627
num Events
259
group Id
EG001
num Affected
68
num At Risk
618
num Events
151
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
228
num At Risk
627
num Events
547
group Id
EG001
num Affected
188
num At Risk
618
num Events
415
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
51
num At Risk
627
num Events
114
group Id
EG001
num Affected
27
num At Risk
618
num Events
48
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
85
num At Risk
627
num Events
100
group Id
EG001
num Affected
29
num At Risk
618
num Events
31
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
56
num At Risk
627
num Events
69
group Id
EG001
num Affected
35
num At Risk
618
num Events
41
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
107
num At Risk
627
num Events
135
group Id
EG001
num Affected
110
num At Risk
618
num Events
132
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
200
num At Risk
627
num Events
338
group Id
EG001
num Affected
175
num At Risk
618
num Events
226
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
37
num At Risk
627
num Events
47
group Id
EG001
num Affected
18
num At Risk
618
num Events
25
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
170
num At Risk
627
num Events
236
group Id
EG001
num Affected
173
num At Risk
618
num Events
256
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
143
num At Risk
627
num Events
245
group Id
EG001
num Affected
81
num At Risk
618
num Events
104
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
88
num At Risk
627
num Events
117
group Id
EG001
num Affected
86
num At Risk
618
num Events
119
term
Vomiting

Complete source fields

description

event Groups

description
On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
id
EG000
other Num Affected
601
other Num At Risk
627
serious Num Affected
284
serious Num At Risk
627
title
Ramucirumab and Docetaxel
description
On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
id
EG001
other Num Affected
583
other Num At Risk
618
serious Num Affected
281
serious Num At Risk
618
title
Placebo and Docetaxel

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
135
num At Risk
627
num Events
306
group Id
EG001
num Affected
174
num At Risk
618
num Events
399
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
79
num At Risk
627
num Events
259
group Id
EG001
num Affected
68
num At Risk
618
num Events
151
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
228
num At Risk
627
num Events
547
group Id
EG001
num Affected
188
num At Risk
618
num Events
415
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
51
num At Risk
627
num Events
114
group Id
EG001
num Affected
27
num At Risk
618
num Events
48
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
85
num At Risk
627
num Events
100
group Id
EG001
num Affected
29
num At Risk
618
num Events
31
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
56
num At Risk
627
num Events
69
group Id
EG001
num Affected
35
num At Risk
618
num Events
41
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
107
num At Risk
627
num Events
135
group Id
EG001
num Affected
110
num At Risk
618
num Events
132
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
200
num At Risk
627
num Events
338
group Id
EG001
num Affected
175
num At Risk
618
num Events
226
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
37
num At Risk
627
num Events
47
group Id
EG001
num Affected
18
num At Risk
618
num Events
25
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
170
num At Risk
627
num Events
236
group Id
EG001
num Affected
173
num At Risk
618
num Events
256
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
143
num At Risk
627
num Events
245
group Id
EG001
num Affected
81
num At Risk
618
num Events
104
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
88
num At Risk
627
num Events
117
group Id
EG001
num Affected
86
num At Risk
618
num Events
119
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
10
num At Risk
627
num Events
16
group Id
EG001
num Affected
14
num At Risk
618
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
86
num At Risk
627
num Events
104
group Id
EG001
num Affected
51
num At Risk
618
num Events
56
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
5
num At Risk
627
num Events
6
group Id
EG001
num Affected
10
num At Risk
618
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
30
num At Risk
627
num Events
38
group Id
EG001
num Affected
27
num At Risk
618
num Events
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
3
num At Risk
627
num Events
3
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
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
627
num Events
0
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
627
num Events
6
group Id
EG001
num Affected
2
num At Risk
618
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
627
num Events
2
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
627
num Events
2
group Id
EG001
num Affected
1
num At Risk
618
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
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
627
num Events
1
group Id
EG001
num Affected
0
num At Risk
618
num Events
0
term
Cardiac failure congestive

time Frame

Randomization through 30 days following last infusion (up to Cycle 38, 21 days/cycle).

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