NCT00982111 · ADVERSE EVENTS

Adverse events

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11

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%

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Necitumumab+Pemetrexed+Cisplatin Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles	158 / 304	296 / 304	236 / 304
Pemetrexed+Cisplatin Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles	130 / 312	303 / 312	246 / 312

Group identifiers: EG000: Necitumumab+Pemetrexed+Cisplatin · EG001: Pemetrexed+Cisplatin

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 12.0
stats
group Id
EG000
num Affected
12
num At Risk
304
num Events
15
group Id
EG001
num Affected
13
num At Risk
312
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
2
num At Risk
312
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
304
num Events
0
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
304
num Events
5
group Id
EG001
num Affected
8
num At Risk
312
num Events
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
9
num At Risk
304
num Events
9
group Id
EG001
num Affected
5
num At Risk
312
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
8
num At Risk
304
num Events
9
group Id
EG001
num Affected
5
num At Risk
312
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
304
num Events
0
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
304
num Events
2
group Id
EG001
num Affected
2
num At Risk
312
num Events
2
term
Atrial fibrillation

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 12.0
stats
group Id
EG000
num Affected
72
num At Risk
304
num Events
155
group Id
EG001
num Affected
91
num At Risk
312
num Events
200
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
45
num At Risk
304
num Events
92
group Id
EG001
num Affected
36
num At Risk
312
num Events
61
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
304
num Events
53
group Id
EG001
num Affected
17
num At Risk
312
num Events
26
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
92
num At Risk
304
num Events
179
group Id
EG001
num Affected
99
num At Risk
312
num Events
217
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
304
num Events
43
group Id
EG001
num Affected
23
num At Risk
312
num Events
42
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
15
num At Risk
304
num Events
18
group Id
EG001
num Affected
16
num At Risk
312
num Events
18
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
31
num At Risk
304
num Events
46
group Id
EG001
num Affected
6
num At Risk
312
num Events
6
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
304
num Events
4
group Id
EG001
num Affected
17
num At Risk
312
num Events
17
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
19
num At Risk
304
num Events
25
group Id
EG001
num Affected
15
num At Risk
312
num Events
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
26
num At Risk
304
num Events
36
group Id
EG001
num Affected
25
num At Risk
312
num Events
29
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
91
num At Risk
304
num Events
133
group Id
EG001
num Affected
83
num At Risk
312
num Events
124
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
90
num At Risk
304
num Events
148
group Id
EG001
num Affected
51
num At Risk
312
num Events
78
term
Diarrhoea

Complete source fields

description

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly

event Groups

deaths Num Affected
236
deaths Num At Risk
304
description
Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
id
EG000
other Num Affected
296
other Num At Risk
304
serious Num Affected
158
serious Num At Risk
304
title
Necitumumab+Pemetrexed+Cisplatin
deaths Num Affected
246
deaths Num At Risk
312
description
Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
id
EG001
other Num Affected
303
other Num At Risk
312
serious Num Affected
130
serious Num At Risk
312
title
Pemetrexed+Cisplatin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
72
num At Risk
304
num Events
155
group Id
EG001
num Affected
91
num At Risk
312
num Events
200
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
45
num At Risk
304
num Events
92
group Id
EG001
num Affected
36
num At Risk
312
num Events
61
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
304
num Events
53
group Id
EG001
num Affected
17
num At Risk
312
num Events
26
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
92
num At Risk
304
num Events
179
group Id
EG001
num Affected
99
num At Risk
312
num Events
217
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
304
num Events
43
group Id
EG001
num Affected
23
num At Risk
312
num Events
42
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
15
num At Risk
304
num Events
18
group Id
EG001
num Affected
16
num At Risk
312
num Events
18
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
31
num At Risk
304
num Events
46
group Id
EG001
num Affected
6
num At Risk
312
num Events
6
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
304
num Events
4
group Id
EG001
num Affected
17
num At Risk
312
num Events
17
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
19
num At Risk
304
num Events
25
group Id
EG001
num Affected
15
num At Risk
312
num Events
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
26
num At Risk
304
num Events
36
group Id
EG001
num Affected
25
num At Risk
312
num Events
29
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
91
num At Risk
304
num Events
133
group Id
EG001
num Affected
83
num At Risk
312
num Events
124
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
90
num At Risk
304
num Events
148
group Id
EG001
num Affected
51
num At Risk
312
num Events
78
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
12
num At Risk
304
num Events
15
group Id
EG001
num Affected
13
num At Risk
312
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
2
num At Risk
312
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
304
num Events
0
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
304
num Events
5
group Id
EG001
num Affected
8
num At Risk
312
num Events
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
9
num At Risk
304
num Events
9
group Id
EG001
num Affected
5
num At Risk
312
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
8
num At Risk
304
num Events
9
group Id
EG001
num Affected
5
num At Risk
312
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
304
num Events
0
group Id
EG001
num Affected
1
num At Risk
312
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
304
num Events
1
group Id
EG001
num Affected
0
num At Risk
312
num Events
0
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
304
num Events
2
group Id
EG001
num Affected
2
num At Risk
312
num Events
2
term
Atrial fibrillation

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