NCT00066573 · ADVERSE EVENTS

Adverse events

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer · Source last updated 2023-08-25

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: 8 years
Other-event reporting threshold: 5%

Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Exemestane Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	19 / 3761	3556 / 3761	Not reported / Not reported
Anastrozole Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally	7 / 3759	3543 / 3759	Not reported / Not reported

Group identifiers: EG000: Exemestane · EG001: Anastrozole

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
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Cardiac ischemia/infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Supraven.arrhyth. Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Ventric.arrhyth. Trigeminy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3761
group Id
EG001
num Affected
1
num At Risk
3759
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3761
group Id
EG001
num Affected
1
num At Risk
3759
term
Nyctalopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Ocular - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Allergic reaction

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
CTCAE (3.0)
stats
group Id
EG000
num Affected
614
num At Risk
3761
group Id
EG001
num Affected
606
num At Risk
3759
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
464
num At Risk
3761
group Id
EG001
num Affected
414
num At Risk
3759
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
399
num At Risk
3761
group Id
EG001
num Affected
363
num At Risk
3759
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
574
num At Risk
3761
group Id
EG001
num Affected
556
num At Risk
3759
term
Heartburn
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
436
num At Risk
3761
group Id
EG001
num Affected
442
num At Risk
3759
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
202
num At Risk
3761
group Id
EG001
num Affected
220
num At Risk
3759
term
Pain Abdomen NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
749
num At Risk
3761
group Id
EG001
num Affected
760
num At Risk
3759
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1697
num At Risk
3761
group Id
EG001
num Affected
1749
num At Risk
3759
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
290
num At Risk
3761
group Id
EG001
num Affected
292
num At Risk
3759
term
Fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
591
num At Risk
3761
group Id
EG001
num Affected
677
num At Risk
3759
term
Cholesterol
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
257
num At Risk
3761
group Id
EG001
num Affected
286
num At Risk
3759
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
229
num At Risk
3761
group Id
EG001
num Affected
218
num At Risk
3759
term
Weight loss

Complete source fields

description

Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.

event Groups

description
Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
id
EG000
other Num Affected
3556
other Num At Risk
3761
serious Num Affected
19
serious Num At Risk
3761
title
Exemestane
description
Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
id
EG001
other Num Affected
3543
other Num At Risk
3759
serious Num Affected
7
serious Num At Risk
3759
title
Anastrozole

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
614
num At Risk
3761
group Id
EG001
num Affected
606
num At Risk
3759
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
464
num At Risk
3761
group Id
EG001
num Affected
414
num At Risk
3759
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
399
num At Risk
3761
group Id
EG001
num Affected
363
num At Risk
3759
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
574
num At Risk
3761
group Id
EG001
num Affected
556
num At Risk
3759
term
Heartburn
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
436
num At Risk
3761
group Id
EG001
num Affected
442
num At Risk
3759
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
202
num At Risk
3761
group Id
EG001
num Affected
220
num At Risk
3759
term
Pain Abdomen NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
749
num At Risk
3761
group Id
EG001
num Affected
760
num At Risk
3759
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1697
num At Risk
3761
group Id
EG001
num Affected
1749
num At Risk
3759
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
290
num At Risk
3761
group Id
EG001
num Affected
292
num At Risk
3759
term
Fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
591
num At Risk
3761
group Id
EG001
num Affected
677
num At Risk
3759
term
Cholesterol
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
257
num At Risk
3761
group Id
EG001
num Affected
286
num At Risk
3759
term
Weight gain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
229
num At Risk
3761
group Id
EG001
num Affected
218
num At Risk
3759
term
Weight loss

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Cardiac ischemia/infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Supraven.arrhyth. Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Ventric.arrhyth. Trigeminy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3761
group Id
EG001
num Affected
1
num At Risk
3759
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3761
group Id
EG001
num Affected
1
num At Risk
3759
term
Nyctalopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Ocular - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3761
group Id
EG001
num Affected
0
num At Risk
3759
term
Allergic reaction

time Frame

8 years

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Preserved source evidence · Not medical advice