NCT00950300 · ADVERSE EVENTS

Adverse events

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer · Source last updated 2018-01-23

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: Approximately 87 months overall
Other-event reporting threshold: 5%

Analysis was performed on Safety Population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Herceptin IV + Chemotherapy Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.	45 / 298	277 / 298	Not reported / Not reported
Herceptin SC + Chemotherapy Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.	65 / 297	283 / 297	Not reported / Not reported

Group identifiers: EG000: Herceptin IV + Chemotherapy · EG001: Herceptin SC + Chemotherapy

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
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Respiratory tract infection viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Lymphorrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
2
num At Risk
297
term
Endometrial cancer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Myeloid leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
2
num At Risk
297
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Goitre
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Emphysema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
10
num At Risk
298
group Id
EG001
num Affected
13
num At Risk
297
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
298
group Id
EG001
num Affected
7
num At Risk
297
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Thrombocytopenia

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
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
188
num At Risk
298
group Id
EG001
num Affected
187
num At Risk
297
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
44
num At Risk
298
group Id
EG001
num Affected
48
num At Risk
297
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
31
num At Risk
298
group Id
EG001
num Affected
29
num At Risk
297
term
Nail disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
18
num At Risk
298
group Id
EG001
num Affected
20
num At Risk
297
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
27
num At Risk
298
group Id
EG001
num Affected
26
num At Risk
297
term
Pruritus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
8
num At Risk
298
group Id
EG001
num Affected
21
num At Risk
297
term
Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
147
num At Risk
298
group Id
EG001
num Affected
145
num At Risk
297
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
109
num At Risk
298
group Id
EG001
num Affected
101
num At Risk
297
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
69
num At Risk
298
group Id
EG001
num Affected
69
num At Risk
297
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
51
num At Risk
298
group Id
EG001
num Affected
57
num At Risk
297
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
45
num At Risk
298
group Id
EG001
num Affected
43
num At Risk
297
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
30
num At Risk
298
group Id
EG001
num Affected
33
num At Risk
297
term
Dyspepsia

Complete source fields

description

Analysis was performed on Safety Population.

event Groups

description
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
id
EG000
other Num Affected
277
other Num At Risk
298
serious Num Affected
45
serious Num At Risk
298
title
Herceptin IV + Chemotherapy
description
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
id
EG001
other Num Affected
283
other Num At Risk
297
serious Num Affected
65
serious Num At Risk
297
title
Herceptin SC + Chemotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
188
num At Risk
298
group Id
EG001
num Affected
187
num At Risk
297
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
44
num At Risk
298
group Id
EG001
num Affected
48
num At Risk
297
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
31
num At Risk
298
group Id
EG001
num Affected
29
num At Risk
297
term
Nail disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
18
num At Risk
298
group Id
EG001
num Affected
20
num At Risk
297
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
27
num At Risk
298
group Id
EG001
num Affected
26
num At Risk
297
term
Pruritus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
8
num At Risk
298
group Id
EG001
num Affected
21
num At Risk
297
term
Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
147
num At Risk
298
group Id
EG001
num Affected
145
num At Risk
297
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
109
num At Risk
298
group Id
EG001
num Affected
101
num At Risk
297
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
69
num At Risk
298
group Id
EG001
num Affected
69
num At Risk
297
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
51
num At Risk
298
group Id
EG001
num Affected
57
num At Risk
297
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
45
num At Risk
298
group Id
EG001
num Affected
43
num At Risk
297
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
30
num At Risk
298
group Id
EG001
num Affected
33
num At Risk
297
term
Dyspepsia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Respiratory tract infection viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Lymphorrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
2
num At Risk
297
term
Endometrial cancer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Myeloid leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
2
num At Risk
297
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Goitre
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
298
group Id
EG001
num Affected
0
num At Risk
297
term
Emphysema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
10
num At Risk
298
group Id
EG001
num Affected
13
num At Risk
297
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
298
group Id
EG001
num Affected
7
num At Risk
297
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
298
group Id
EG001
num Affected
1
num At Risk
297
term
Thrombocytopenia

time Frame

Approximately 87 months overall

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Preserved source evidence · Not medical advice