NCT00981058 · ADVERSE EVENTS

Adverse events

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin · Source last updated 2025-06-18

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: Baseline Up To 156 Months
Other-event reporting threshold: 5%

All participants who received at least one dose of study drug. The adverse events were analyzed and reported according to the study treatments pre-specified in the statistical analysis plan.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.	262 / 538	518 / 538	476 / 538
Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.	208 / 541	512 / 541	487 / 541

Group identifiers: EG000: Necitumumab + Gemcitabine + Cisplatin · EG001: Gemcitabine + 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 27.1
stats
group Id
EG000
num Affected
1
num At Risk
538
num Events
1
group Id
EG001
num Affected
0
num At Risk
541
num Events
0
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
22
num At Risk
538
num Events
22
group Id
EG001
num Affected
17
num At Risk
541
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
7
num At Risk
541
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
4
num At Risk
541
num Events
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
538
num Events
0
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
20
num At Risk
538
num Events
20
group Id
EG001
num Affected
33
num At Risk
541
num Events
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
3
num At Risk
541
num Events
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
17
num At Risk
538
num Events
17
group Id
EG001
num Affected
20
num At Risk
541
num Events
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
538
num Events
1
group Id
EG001
num Affected
0
num At Risk
541
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
538
num Events
0
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
538
num Events
2
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
3
num At Risk
538
num Events
3
group Id
EG001
num Affected
4
num At Risk
541
num Events
4
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 27.1
stats
group Id
EG000
num Affected
221
num At Risk
538
num Events
221
group Id
EG001
num Affected
246
num At Risk
541
num Events
246
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
71
num At Risk
538
num Events
71
group Id
EG001
num Affected
85
num At Risk
541
num Events
85
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
220
num At Risk
538
num Events
220
group Id
EG001
num Affected
229
num At Risk
541
num Events
229
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
103
num At Risk
538
num Events
103
group Id
EG001
num Affected
124
num At Risk
541
num Events
124
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
31
num At Risk
538
num Events
31
group Id
EG001
num Affected
29
num At Risk
541
num Events
29
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
111
num At Risk
538
num Events
111
group Id
EG001
num Affected
101
num At Risk
541
num Events
101
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
84
num At Risk
538
num Events
84
group Id
EG001
num Affected
60
num At Risk
541
num Events
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
27
num At Risk
538
num Events
27
group Id
EG001
num Affected
22
num At Risk
541
num Events
22
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
265
num At Risk
538
num Events
265
group Id
EG001
num Affected
284
num At Risk
541
num Events
284
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
58
num At Risk
538
num Events
58
group Id
EG001
num Affected
32
num At Risk
541
num Events
32
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
153
num At Risk
538
num Events
153
group Id
EG001
num Affected
134
num At Risk
541
num Events
134
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
125
num At Risk
538
num Events
125
group Id
EG001
num Affected
112
num At Risk
541
num Events
112
term
Asthenia

Complete source fields

description

All participants who received at least one dose of study drug. The adverse events were analyzed and reported according to the study treatments pre-specified in the statistical analysis plan.

event Groups

deaths Num Affected
476
deaths Num At Risk
538
description
Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
id
EG000
other Num Affected
518
other Num At Risk
538
serious Num Affected
262
serious Num At Risk
538
title
Necitumumab + Gemcitabine + Cisplatin
deaths Num Affected
487
deaths Num At Risk
541
description
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
id
EG001
other Num Affected
512
other Num At Risk
541
serious Num Affected
208
serious Num At Risk
541
title
Gemcitabine + Cisplatin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
221
num At Risk
538
num Events
221
group Id
EG001
num Affected
246
num At Risk
541
num Events
246
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
71
num At Risk
538
num Events
71
group Id
EG001
num Affected
85
num At Risk
541
num Events
85
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
220
num At Risk
538
num Events
220
group Id
EG001
num Affected
229
num At Risk
541
num Events
229
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
103
num At Risk
538
num Events
103
group Id
EG001
num Affected
124
num At Risk
541
num Events
124
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
31
num At Risk
538
num Events
31
group Id
EG001
num Affected
29
num At Risk
541
num Events
29
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
111
num At Risk
538
num Events
111
group Id
EG001
num Affected
101
num At Risk
541
num Events
101
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
84
num At Risk
538
num Events
84
group Id
EG001
num Affected
60
num At Risk
541
num Events
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
27
num At Risk
538
num Events
27
group Id
EG001
num Affected
22
num At Risk
541
num Events
22
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
265
num At Risk
538
num Events
265
group Id
EG001
num Affected
284
num At Risk
541
num Events
284
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
58
num At Risk
538
num Events
58
group Id
EG001
num Affected
32
num At Risk
541
num Events
32
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
153
num At Risk
538
num Events
153
group Id
EG001
num Affected
134
num At Risk
541
num Events
134
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
125
num At Risk
538
num Events
125
group Id
EG001
num Affected
112
num At Risk
541
num Events
112
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
538
num Events
1
group Id
EG001
num Affected
0
num At Risk
541
num Events
0
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
22
num At Risk
538
num Events
22
group Id
EG001
num Affected
17
num At Risk
541
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
7
num At Risk
541
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
4
num At Risk
541
num Events
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
538
num Events
0
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
20
num At Risk
538
num Events
20
group Id
EG001
num Affected
33
num At Risk
541
num Events
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
6
num At Risk
538
num Events
6
group Id
EG001
num Affected
3
num At Risk
541
num Events
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
17
num At Risk
538
num Events
17
group Id
EG001
num Affected
20
num At Risk
541
num Events
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
1
num At Risk
538
num Events
1
group Id
EG001
num Affected
0
num At Risk
541
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
0
num At Risk
538
num Events
0
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
2
num At Risk
538
num Events
2
group Id
EG001
num Affected
1
num At Risk
541
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.1
stats
group Id
EG000
num Affected
3
num At Risk
538
num Events
3
group Id
EG001
num Affected
4
num At Risk
541
num Events
4
term
Atrial fibrillation

time Frame

Baseline Up To 156 Months

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Preserved source evidence · Not medical advice