NCT00789373 · ADVERSE EVENTS

Adverse events

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer · Source last updated 2018-12-14

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: From start of study up to approximately 108 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Induction Pemetrexed + Cisplatin pemetrexed: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles. cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles.	257 / 939	759 / 939	Not reported / Not reported
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care	94 / 359	287 / 359	Not reported / Not reported
Pemetrexed + Cisplatin Followed by Placebo pemetrexed and cisplatin followed by placebo plus best supportive care	36 / 180	117 / 180	Not reported / Not reported

Group identifiers: EG000: Induction Pemetrexed + Cisplatin · EG001: Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed · EG002: Pemetrexed + Cisplatin Followed by 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 21.0
stats
group Id
EG000
num Affected
13
num At Risk
939
num Events
30
group Id
EG001
num Affected
11
num At Risk
359
num Events
21
group Id
EG002
num Affected
1
num At Risk
180
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
939
num Events
0
group Id
EG001
num Affected
1
num At Risk
359
num Events
2
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
1
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
12
num At Risk
939
num Events
13
group Id
EG001
num Affected
6
num At Risk
359
num Events
6
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
3
num At Risk
939
num Events
3
group Id
EG001
num Affected
2
num At Risk
359
num Events
3
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
8
num At Risk
939
num Events
9
group Id
EG001
num Affected
6
num At Risk
359
num Events
8
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
7
num At Risk
939
num Events
9
group Id
EG001
num Affected
5
num At Risk
359
num Events
8
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
3
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
1
group Id
EG001
num Affected
1
num At Risk
359
num Events
1
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
939
num Events
0
group Id
EG001
num Affected
1
num At Risk
359
num Events
1
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
4
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
3
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Atrial tachycardia

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 21.0
stats
group Id
EG000
num Affected
152
num At Risk
939
num Events
600
group Id
EG001
num Affected
76
num At Risk
359
num Events
295
group Id
EG002
num Affected
5
num At Risk
180
num Events
11
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
158
num At Risk
939
num Events
340
group Id
EG001
num Affected
38
num At Risk
359
num Events
100
group Id
EG002
num Affected
3
num At Risk
180
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
131
num At Risk
939
num Events
339
group Id
EG001
num Affected
23
num At Risk
359
num Events
110
group Id
EG002
num Affected
14
num At Risk
180
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
114
num At Risk
939
num Events
175
group Id
EG001
num Affected
28
num At Risk
359
num Events
44
group Id
EG002
num Affected
7
num At Risk
180
num Events
16
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
362
num At Risk
939
num Events
932
group Id
EG001
num Affected
69
num At Risk
359
num Events
286
group Id
EG002
num Affected
8
num At Risk
180
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
210
num At Risk
939
num Events
366
group Id
EG001
num Affected
42
num At Risk
359
num Events
78
group Id
EG002
num Affected
9
num At Risk
180
num Events
14
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
141
num At Risk
939
num Events
494
group Id
EG001
num Affected
51
num At Risk
359
num Events
325
group Id
EG002
num Affected
8
num At Risk
180
num Events
16
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
44
num At Risk
939
num Events
139
group Id
EG001
num Affected
18
num At Risk
359
num Events
77
group Id
EG002
num Affected
6
num At Risk
180
num Events
13
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
181
num At Risk
939
num Events
743
group Id
EG001
num Affected
55
num At Risk
359
num Events
316
group Id
EG002
num Affected
16
num At Risk
180
num Events
61
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
50
num At Risk
939
num Events
83
group Id
EG001
num Affected
21
num At Risk
359
num Events
50
group Id
EG002
num Affected
5
num At Risk
180
num Events
9
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
42
num At Risk
939
num Events
168
group Id
EG001
num Affected
45
num At Risk
359
num Events
314
group Id
EG002
num Affected
5
num At Risk
180
num Events
18
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
46
num At Risk
939
num Events
63
group Id
EG001
num Affected
38
num At Risk
359
num Events
65
group Id
EG002
num Affected
7
num At Risk
180
num Events
7
term
Pyrexia

Complete source fields

event Groups

description
pemetrexed: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles. cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles.
id
EG000
other Num Affected
759
other Num At Risk
939
serious Num Affected
257
serious Num At Risk
939
title
Induction Pemetrexed + Cisplatin
description
pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
id
EG001
other Num Affected
287
other Num At Risk
359
serious Num Affected
94
serious Num At Risk
359
title
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
description
pemetrexed and cisplatin followed by placebo plus best supportive care
id
EG002
other Num Affected
117
other Num At Risk
180
serious Num Affected
36
serious Num At Risk
180
title
Pemetrexed + Cisplatin Followed by Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
152
num At Risk
939
num Events
600
group Id
EG001
num Affected
76
num At Risk
359
num Events
295
group Id
EG002
num Affected
5
num At Risk
180
num Events
11
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
158
num At Risk
939
num Events
340
group Id
EG001
num Affected
38
num At Risk
359
num Events
100
group Id
EG002
num Affected
3
num At Risk
180
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
131
num At Risk
939
num Events
339
group Id
EG001
num Affected
23
num At Risk
359
num Events
110
group Id
EG002
num Affected
14
num At Risk
180
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
114
num At Risk
939
num Events
175
group Id
EG001
num Affected
28
num At Risk
359
num Events
44
group Id
EG002
num Affected
7
num At Risk
180
num Events
16
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
362
num At Risk
939
num Events
932
group Id
EG001
num Affected
69
num At Risk
359
num Events
286
group Id
EG002
num Affected
8
num At Risk
180
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
210
num At Risk
939
num Events
366
group Id
EG001
num Affected
42
num At Risk
359
num Events
78
group Id
EG002
num Affected
9
num At Risk
180
num Events
14
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
141
num At Risk
939
num Events
494
group Id
EG001
num Affected
51
num At Risk
359
num Events
325
group Id
EG002
num Affected
8
num At Risk
180
num Events
16
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
44
num At Risk
939
num Events
139
group Id
EG001
num Affected
18
num At Risk
359
num Events
77
group Id
EG002
num Affected
6
num At Risk
180
num Events
13
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
181
num At Risk
939
num Events
743
group Id
EG001
num Affected
55
num At Risk
359
num Events
316
group Id
EG002
num Affected
16
num At Risk
180
num Events
61
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
50
num At Risk
939
num Events
83
group Id
EG001
num Affected
21
num At Risk
359
num Events
50
group Id
EG002
num Affected
5
num At Risk
180
num Events
9
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
42
num At Risk
939
num Events
168
group Id
EG001
num Affected
45
num At Risk
359
num Events
314
group Id
EG002
num Affected
5
num At Risk
180
num Events
18
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
46
num At Risk
939
num Events
63
group Id
EG001
num Affected
38
num At Risk
359
num Events
65
group Id
EG002
num Affected
7
num At Risk
180
num Events
7
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
13
num At Risk
939
num Events
30
group Id
EG001
num Affected
11
num At Risk
359
num Events
21
group Id
EG002
num Affected
1
num At Risk
180
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
939
num Events
0
group Id
EG001
num Affected
1
num At Risk
359
num Events
2
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
1
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
12
num At Risk
939
num Events
13
group Id
EG001
num Affected
6
num At Risk
359
num Events
6
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
3
num At Risk
939
num Events
3
group Id
EG001
num Affected
2
num At Risk
359
num Events
3
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
8
num At Risk
939
num Events
9
group Id
EG001
num Affected
6
num At Risk
359
num Events
8
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
7
num At Risk
939
num Events
9
group Id
EG001
num Affected
5
num At Risk
359
num Events
8
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
3
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
1
group Id
EG001
num Affected
1
num At Risk
359
num Events
1
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
939
num Events
0
group Id
EG001
num Affected
1
num At Risk
359
num Events
1
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
4
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
939
num Events
3
group Id
EG001
num Affected
0
num At Risk
359
num Events
0
group Id
EG002
num Affected
0
num At Risk
180
num Events
0
term
Atrial tachycardia

time Frame

From start of study up to approximately 108 months

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Preserved source evidence · Not medical advice