NCT00005957 · ADVERSE EVENTS

Adverse events

Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer · Source last updated 2023-08-21

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: 10 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Standard Breast Irradiation radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields. Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.	1 / 927	745 / 927	Not reported / Not reported
Breast Radiation Plus Regional Radiation regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields. Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.	3 / 893	752 / 893	Not reported / Not reported

Group identifiers: EG000: Standard Breast Irradiation · EG001: Breast Radiation Plus Regional Radiation

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
927
group Id
EG001
num Affected
3
num At Risk
893
term
Secondary Malignancy

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
180
num At Risk
927
group Id
EG001
num Affected
226
num At Risk
893
term
Lymphedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
353
num At Risk
927
group Id
EG001
num Affected
343
num At Risk
893
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
252
num At Risk
927
group Id
EG001
num Affected
233
num At Risk
893
term
Pain due to radiation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
69
num At Risk
927
group Id
EG001
num Affected
89
num At Risk
893
term
Joint
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
313
num At Risk
927
group Id
EG001
num Affected
316
num At Risk
893
term
Skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
167
num At Risk
927
group Id
EG001
num Affected
180
num At Risk
893
term
Subcutaneous tissue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
126
num At Risk
927
group Id
EG001
num Affected
130
num At Risk
893
term
Radiation dermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
131
num At Risk
927
group Id
EG001
num Affected
157
num At Risk
893
term
Muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
197
num At Risk
927
group Id
EG001
num Affected
217
num At Risk
893
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
187
num At Risk
927
group Id
EG001
num Affected
218
num At Risk
893
term
Neuropathy-sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
110
num At Risk
927
group Id
EG001
num Affected
96
num At Risk
893
term
Neuropathic pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
283
num At Risk
927
group Id
EG001
num Affected
256
num At Risk
893
term
Gynecomastia

Complete source fields

event Groups

description
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields. Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.
id
EG000
other Num Affected
745
other Num At Risk
927
serious Num Affected
1
serious Num At Risk
927
title
Standard Breast Irradiation
description
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields. Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.
id
EG001
other Num Affected
752
other Num At Risk
893
serious Num Affected
3
serious Num At Risk
893
title
Breast Radiation Plus Regional Radiation

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
180
num At Risk
927
group Id
EG001
num Affected
226
num At Risk
893
term
Lymphedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
353
num At Risk
927
group Id
EG001
num Affected
343
num At Risk
893
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
252
num At Risk
927
group Id
EG001
num Affected
233
num At Risk
893
term
Pain due to radiation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
69
num At Risk
927
group Id
EG001
num Affected
89
num At Risk
893
term
Joint
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
313
num At Risk
927
group Id
EG001
num Affected
316
num At Risk
893
term
Skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
167
num At Risk
927
group Id
EG001
num Affected
180
num At Risk
893
term
Subcutaneous tissue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
126
num At Risk
927
group Id
EG001
num Affected
130
num At Risk
893
term
Radiation dermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
131
num At Risk
927
group Id
EG001
num Affected
157
num At Risk
893
term
Muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
197
num At Risk
927
group Id
EG001
num Affected
217
num At Risk
893
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
187
num At Risk
927
group Id
EG001
num Affected
218
num At Risk
893
term
Neuropathy-sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
110
num At Risk
927
group Id
EG001
num Affected
96
num At Risk
893
term
Neuropathic pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
283
num At Risk
927
group Id
EG001
num Affected
256
num At Risk
893
term
Gynecomastia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
927
group Id
EG001
num Affected
3
num At Risk
893
term
Secondary Malignancy

time Frame

10 years

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Preserved source evidence · Not medical advice