NCT00513292 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery · Source last updated 2019-01-23

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 affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies	19 / 138	136 / 138	Not reported / Not reported
Arm B Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies	26 / 142	141 / 142	Not reported / Not reported

Group identifiers: EG000: Arm A · EG001: Arm B

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 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
3
num At Risk
142
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
8
num At Risk
138
num Events
12
group Id
EG001
num Affected
11
num At Risk
142
num Events
14
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
3
group Id
EG001
num Affected
5
num At Risk
142
num Events
6
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Eyelid function disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Vision blurred

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 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
6
group Id
EG001
num Affected
5
num At Risk
142
num Events
7
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
138
num Events
3
group Id
EG001
num Affected
3
num At Risk
142
num Events
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
53
num At Risk
138
num Events
279
group Id
EG001
num Affected
50
num At Risk
142
num Events
269
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
2
num At Risk
142
num Events
8
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
2
num At Risk
142
num Events
5
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
138
num Events
2
group Id
EG001
num Affected
5
num At Risk
142
num Events
8
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
4
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
2
num At Risk
142
num Events
2
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
9
num At Risk
138
num Events
14
group Id
EG001
num Affected
18
num At Risk
142
num Events
25
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Myocardial ischemia

Complete source fields

event Groups

description
Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
136
other Num At Risk
138
serious Num Affected
19
serious Num At Risk
138
title
Arm A
description
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
141
other Num At Risk
142
serious Num Affected
26
serious Num At Risk
142
title
Arm B

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
6
group Id
EG001
num Affected
5
num At Risk
142
num Events
7
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
138
num Events
3
group Id
EG001
num Affected
3
num At Risk
142
num Events
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
53
num At Risk
138
num Events
279
group Id
EG001
num Affected
50
num At Risk
142
num Events
269
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
2
num At Risk
142
num Events
8
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
2
num At Risk
142
num Events
5
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
138
num Events
2
group Id
EG001
num Affected
5
num At Risk
142
num Events
8
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
4
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
2
num At Risk
142
num Events
2
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
9
num At Risk
138
num Events
14
group Id
EG001
num Affected
18
num At Risk
142
num Events
25
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Myocardial ischemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
3
num At Risk
142
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
8
num At Risk
138
num Events
12
group Id
EG001
num Affected
11
num At Risk
142
num Events
14
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
138
num Events
3
group Id
EG001
num Affected
5
num At Risk
142
num Events
6
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
138
num Events
1
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Eyelid function disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
138
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Vision blurred

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Preserved source evidence · Not medical advice