NCT00256698 · ADVERSE EVENTS

Adverse events

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy · Source last updated 2012-08-01

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Fulvestrant + Anastrozole Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg	40 / 256	161 / 256	Not reported / Not reported
Anastrozole Anastrozole 1 mg	45 / 254	178 / 254	Not reported / Not reported

Group identifiers: EG000: Fulvestrant + Anastrozole · 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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
2
num At Risk
254
term
Pericardial Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Atrial Flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Ventricular Arrhythmia

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
MedDRA 10.0
stats
group Id
EG000
num Affected
23
num At Risk
256
group Id
EG001
num Affected
27
num At Risk
254
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
15
num At Risk
256
group Id
EG001
num Affected
12
num At Risk
254
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
15
num At Risk
256
group Id
EG001
num Affected
13
num At Risk
254
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
13
num At Risk
256
group Id
EG001
num Affected
9
num At Risk
254
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
27
num At Risk
256
group Id
EG001
num Affected
33
num At Risk
254
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
14
num At Risk
256
group Id
EG001
num Affected
8
num At Risk
254
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
30
num At Risk
256
group Id
EG001
num Affected
27
num At Risk
254
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
8
num At Risk
256
group Id
EG001
num Affected
20
num At Risk
254
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
11
num At Risk
256
group Id
EG001
num Affected
15
num At Risk
254
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
10
num At Risk
256
group Id
EG001
num Affected
13
num At Risk
254
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
13
num At Risk
256
group Id
EG001
num Affected
9
num At Risk
254
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
21
num At Risk
256
group Id
EG001
num Affected
19
num At Risk
254
term
Hot flush

Complete source fields

event Groups

description
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
id
EG000
other Num Affected
161
other Num At Risk
256
serious Num Affected
40
serious Num At Risk
256
title
Fulvestrant + Anastrozole
description
Anastrozole 1 mg
id
EG001
other Num Affected
178
other Num At Risk
254
serious Num Affected
45
serious Num At Risk
254
title
Anastrozole

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
23
num At Risk
256
group Id
EG001
num Affected
27
num At Risk
254
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
15
num At Risk
256
group Id
EG001
num Affected
12
num At Risk
254
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
15
num At Risk
256
group Id
EG001
num Affected
13
num At Risk
254
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
13
num At Risk
256
group Id
EG001
num Affected
9
num At Risk
254
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
27
num At Risk
256
group Id
EG001
num Affected
33
num At Risk
254
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
14
num At Risk
256
group Id
EG001
num Affected
8
num At Risk
254
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
30
num At Risk
256
group Id
EG001
num Affected
27
num At Risk
254
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
8
num At Risk
256
group Id
EG001
num Affected
20
num At Risk
254
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
11
num At Risk
256
group Id
EG001
num Affected
15
num At Risk
254
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
10
num At Risk
256
group Id
EG001
num Affected
13
num At Risk
254
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
13
num At Risk
256
group Id
EG001
num Affected
9
num At Risk
254
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
21
num At Risk
256
group Id
EG001
num Affected
19
num At Risk
254
term
Hot flush

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
2
num At Risk
254
term
Pericardial Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Atrial Flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
256
group Id
EG001
num Affected
1
num At Risk
254
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
256
group Id
EG001
num Affected
0
num At Risk
254
term
Ventricular Arrhythmia

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