NCT00045032 · ADVERSE EVENTS

Adverse events

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer · Source last updated 2017-04-27

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 Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)
Other-event reporting threshold: 5%

Analysis Population Description: Safety Population

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Observation Arm Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.	143 / 1744	1076 / 1744	Not reported / Not reported
Herceptin 1-Year Arm Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.	269 / 1682	1389 / 1682	Not reported / Not reported
Herceptin 2-Year Arm Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.	344 / 1673	1440 / 1673	Not reported / Not reported

Group identifiers: EG000: Observation Arm · EG001: Herceptin 1-Year Arm · EG002: Herceptin 2-Year Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
1744
group Id
EG001
num Affected
2
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
2
num At Risk
1673
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Atrioventricular block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Atrioventricular block complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Bradycardia

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
18
num At Risk
1744
group Id
EG001
num Affected
78
num At Risk
1682
group Id
EG002
num Affected
127
num At Risk
1673
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
20
num At Risk
1744
group Id
EG001
num Affected
72
num At Risk
1682
group Id
EG002
num Affected
84
num At Risk
1673
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
22
num At Risk
1744
group Id
EG001
num Affected
155
num At Risk
1682
group Id
EG002
num Affected
180
num At Risk
1673
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
37
num At Risk
1744
group Id
EG001
num Affected
134
num At Risk
1682
group Id
EG002
num Affected
157
num At Risk
1673
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
15
num At Risk
1744
group Id
EG001
num Affected
77
num At Risk
1682
group Id
EG002
num Affected
99
num At Risk
1673
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
42
num At Risk
1744
group Id
EG001
num Affected
102
num At Risk
1682
group Id
EG002
num Affected
119
num At Risk
1673
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
37
num At Risk
1744
group Id
EG001
num Affected
63
num At Risk
1682
group Id
EG002
num Affected
84
num At Risk
1673
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
99
num At Risk
1682
group Id
EG002
num Affected
128
num At Risk
1673
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
83
num At Risk
1744
group Id
EG001
num Affected
198
num At Risk
1682
group Id
EG002
num Affected
246
num At Risk
1673
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
49
num At Risk
1744
group Id
EG001
num Affected
82
num At Risk
1682
group Id
EG002
num Affected
101
num At Risk
1673
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
12
num At Risk
1744
group Id
EG001
num Affected
116
num At Risk
1682
group Id
EG002
num Affected
145
num At Risk
1673
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
17
num At Risk
1744
group Id
EG001
num Affected
95
num At Risk
1682
group Id
EG002
num Affected
142
num At Risk
1673
term
Influenza

Complete source fields

description

Analysis Population Description: Safety Population

event Groups

description
Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.
id
EG000
other Num Affected
1076
other Num At Risk
1744
serious Num Affected
143
serious Num At Risk
1744
title
Observation Arm
description
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
id
EG001
other Num Affected
1389
other Num At Risk
1682
serious Num Affected
269
serious Num At Risk
1682
title
Herceptin 1-Year Arm
description
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
id
EG002
other Num Affected
1440
other Num At Risk
1673
serious Num Affected
344
serious Num At Risk
1673
title
Herceptin 2-Year Arm

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
18
num At Risk
1744
group Id
EG001
num Affected
78
num At Risk
1682
group Id
EG002
num Affected
127
num At Risk
1673
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
20
num At Risk
1744
group Id
EG001
num Affected
72
num At Risk
1682
group Id
EG002
num Affected
84
num At Risk
1673
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
22
num At Risk
1744
group Id
EG001
num Affected
155
num At Risk
1682
group Id
EG002
num Affected
180
num At Risk
1673
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
37
num At Risk
1744
group Id
EG001
num Affected
134
num At Risk
1682
group Id
EG002
num Affected
157
num At Risk
1673
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
15
num At Risk
1744
group Id
EG001
num Affected
77
num At Risk
1682
group Id
EG002
num Affected
99
num At Risk
1673
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
42
num At Risk
1744
group Id
EG001
num Affected
102
num At Risk
1682
group Id
EG002
num Affected
119
num At Risk
1673
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
37
num At Risk
1744
group Id
EG001
num Affected
63
num At Risk
1682
group Id
EG002
num Affected
84
num At Risk
1673
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
99
num At Risk
1682
group Id
EG002
num Affected
128
num At Risk
1673
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
83
num At Risk
1744
group Id
EG001
num Affected
198
num At Risk
1682
group Id
EG002
num Affected
246
num At Risk
1673
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
49
num At Risk
1744
group Id
EG001
num Affected
82
num At Risk
1682
group Id
EG002
num Affected
101
num At Risk
1673
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
12
num At Risk
1744
group Id
EG001
num Affected
116
num At Risk
1682
group Id
EG002
num Affected
145
num At Risk
1673
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
17
num At Risk
1744
group Id
EG001
num Affected
95
num At Risk
1682
group Id
EG002
num Affected
142
num At Risk
1673
term
Influenza

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
1744
group Id
EG001
num Affected
2
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
2
num At Risk
1673
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
0
num At Risk
1682
group Id
EG002
num Affected
1
num At Risk
1673
term
Atrioventricular block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Atrioventricular block complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
0
num At Risk
1744
group Id
EG001
num Affected
1
num At Risk
1682
group Id
EG002
num Affected
0
num At Risk
1673
term
Bradycardia

time Frame

From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)

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