NCT00102804 · ADVERSE EVENTS

Adverse events

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2014-12-29

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: 0%

Participants are reported under the treatment to which they received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pemetrexed and BSC Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.	83 / 438	386 / 438	Not reported / Not reported
Placebo and BSC Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.	31 / 218	178 / 218	Not reported / Not reported

Group identifiers: EG000: Pemetrexed and BSC · EG001: Placebo and BSC

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 11.0
stats
group Id
EG000
num Affected
6
num At Risk
438
num Events
7
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
4
num At Risk
438
num Events
4
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
438
num Events
2
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
3
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Myocardial ischaemia

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 11.0
stats
group Id
EG000
num Affected
65
num At Risk
438
num Events
97
group Id
EG001
num Affected
12
num At Risk
218
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
25
num At Risk
438
num Events
64
group Id
EG001
num Affected
5
num At Risk
218
num Events
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
4
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
3
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
21
num At Risk
438
num Events
66
group Id
EG001
num Affected
5
num At Risk
218
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
438
num Events
2
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Thrombocythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
17
num At Risk
438
num Events
29
group Id
EG001
num Affected
2
num At Risk
218
num Events
3
term
Thrombocytopenia

Complete source fields

description

Participants are reported under the treatment to which they received.

event Groups

description
Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
id
EG000
other Num Affected
386
other Num At Risk
438
serious Num Affected
83
serious Num At Risk
438
title
Pemetrexed and BSC
description
Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
id
EG001
other Num Affected
178
other Num At Risk
218
serious Num Affected
31
serious Num At Risk
218
title
Placebo and BSC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
65
num At Risk
438
num Events
97
group Id
EG001
num Affected
12
num At Risk
218
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
25
num At Risk
438
num Events
64
group Id
EG001
num Affected
5
num At Risk
218
num Events
8
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
4
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
3
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
21
num At Risk
438
num Events
66
group Id
EG001
num Affected
5
num At Risk
218
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
438
num Events
2
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Thrombocythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
17
num At Risk
438
num Events
29
group Id
EG001
num Affected
2
num At Risk
218
num Events
3
term
Thrombocytopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
6
num At Risk
438
num Events
7
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
4
num At Risk
438
num Events
4
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
438
num Events
2
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
3
num At Risk
438
num Events
3
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
438
num Events
0
group Id
EG001
num Affected
1
num At Risk
218
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
438
num Events
1
group Id
EG001
num Affected
0
num At Risk
218
num Events
0
term
Myocardial ischaemia

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