NCT00878709 · ADVERSE EVENTS

Adverse events

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer · Source last updated 2021-06-11

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: From first dose through 28 days after the last dose, up to two years.
Other-event reporting threshold: 5%

The safety population included all participants who received at least one dose of investigational product.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.	103 / 1408	1386 / 1408	Not reported / Not reported
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.	85 / 1408	1234 / 1408	Not reported / Not reported

Group identifiers: EG000: Neratinib · EG001: 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 (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
0
num At Risk
1408
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
22
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
12
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
4
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
1408
group Id
EG001
num Affected
0
num At Risk
1408
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Pancreatitis

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
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1341
num At Risk
1408
group Id
EG001
num Affected
499
num At Risk
1408
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
605
num At Risk
1408
group Id
EG001
num Affected
303
num At Risk
1408
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
364
num At Risk
1408
group Id
EG001
num Affected
113
num At Risk
1408
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
339
num At Risk
1408
group Id
EG001
num Affected
144
num At Risk
1408
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
212
num At Risk
1408
group Id
EG001
num Affected
96
num At Risk
1408
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
139
num At Risk
1408
group Id
EG001
num Affected
59
num At Risk
1408
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
115
num At Risk
1408
group Id
EG001
num Affected
134
num At Risk
1408
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
85
num At Risk
1408
group Id
EG001
num Affected
29
num At Risk
1408
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
73
num At Risk
1408
group Id
EG001
num Affected
49
num At Risk
1408
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
381
num At Risk
1408
group Id
EG001
num Affected
283
num At Risk
1408
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
107
num At Risk
1408
group Id
EG001
num Affected
110
num At Risk
1408
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
77
num At Risk
1408
group Id
EG001
num Affected
54
num At Risk
1408
term
Pyrexia

Complete source fields

description

The safety population included all participants who received at least one dose of investigational product.

event Groups

description
Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
id
EG000
other Num Affected
1386
other Num At Risk
1408
serious Num Affected
103
serious Num At Risk
1408
title
Neratinib
description
Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
id
EG001
other Num Affected
1234
other Num At Risk
1408
serious Num Affected
85
serious Num At Risk
1408
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1341
num At Risk
1408
group Id
EG001
num Affected
499
num At Risk
1408
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
605
num At Risk
1408
group Id
EG001
num Affected
303
num At Risk
1408
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
364
num At Risk
1408
group Id
EG001
num Affected
113
num At Risk
1408
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
339
num At Risk
1408
group Id
EG001
num Affected
144
num At Risk
1408
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
212
num At Risk
1408
group Id
EG001
num Affected
96
num At Risk
1408
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
139
num At Risk
1408
group Id
EG001
num Affected
59
num At Risk
1408
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
115
num At Risk
1408
group Id
EG001
num Affected
134
num At Risk
1408
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
85
num At Risk
1408
group Id
EG001
num Affected
29
num At Risk
1408
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
73
num At Risk
1408
group Id
EG001
num Affected
49
num At Risk
1408
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
381
num At Risk
1408
group Id
EG001
num Affected
283
num At Risk
1408
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
107
num At Risk
1408
group Id
EG001
num Affected
110
num At Risk
1408
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
77
num At Risk
1408
group Id
EG001
num Affected
54
num At Risk
1408
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
0
num At Risk
1408
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
22
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
12
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
4
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
1408
group Id
EG001
num Affected
0
num At Risk
1408
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
1408
group Id
EG001
num Affected
1
num At Risk
1408
term
Pancreatitis

time Frame

From first dose through 28 days after the last dose, up to two years.

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Preserved source evidence · Not medical advice