NCT01602380 · ADVERSE EVENTS

Adverse events

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. · Source last updated 2026-02-27

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: 116 months (duration from first patient enrolled to data cut-off for the final analysis)
Other-event reporting threshold: 5%

All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Fulvestrant 500 mg Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).	39 / 228	125 / 228	157 / 230
Anastrozole 1 mg Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).	36 / 232	127 / 232	159 / 232

Group identifiers: EG000: Fulvestrant 500 mg · EG001: Anastrozole 1 mg

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 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
2
num At Risk
232
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Anaemia macrocytic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Skin abrasion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Colorectal cancer

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
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
228
num Events
10
group Id
EG001
num Affected
20
num At Risk
232
num Events
21
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
15
group Id
EG001
num Affected
9
num At Risk
232
num Events
12
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
29
num At Risk
228
num Events
35
group Id
EG001
num Affected
18
num At Risk
232
num Events
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
15
group Id
EG001
num Affected
10
num At Risk
232
num Events
23
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
11
num At Risk
228
num Events
11
group Id
EG001
num Affected
14
num At Risk
232
num Events
15
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
228
num Events
18
group Id
EG001
num Affected
8
num At Risk
232
num Events
8
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
9
num At Risk
232
num Events
9
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
42
num At Risk
228
num Events
65
group Id
EG001
num Affected
31
num At Risk
232
num Events
40
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
22
num At Risk
228
num Events
25
group Id
EG001
num Affected
18
num At Risk
232
num Events
19
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
228
num Events
19
group Id
EG001
num Affected
8
num At Risk
232
num Events
11
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
17
num At Risk
228
num Events
22
group Id
EG001
num Affected
11
num At Risk
232
num Events
15
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
12
num At Risk
232
num Events
12
term
Headache

Complete source fields

description

event Groups

deaths Num Affected
157
deaths Num At Risk
230
description
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
id
EG000
other Num Affected
125
other Num At Risk
228
serious Num Affected
39
serious Num At Risk
228
title
Fulvestrant 500 mg
deaths Num Affected
159
deaths Num At Risk
232
description
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
id
EG001
other Num Affected
127
other Num At Risk
232
serious Num Affected
36
serious Num At Risk
232
title
Anastrozole 1 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
228
num Events
10
group Id
EG001
num Affected
20
num At Risk
232
num Events
21
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
15
group Id
EG001
num Affected
9
num At Risk
232
num Events
12
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
29
num At Risk
228
num Events
35
group Id
EG001
num Affected
18
num At Risk
232
num Events
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
15
group Id
EG001
num Affected
10
num At Risk
232
num Events
23
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
11
num At Risk
228
num Events
11
group Id
EG001
num Affected
14
num At Risk
232
num Events
15
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
228
num Events
18
group Id
EG001
num Affected
8
num At Risk
232
num Events
8
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
9
num At Risk
232
num Events
9
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
42
num At Risk
228
num Events
65
group Id
EG001
num Affected
31
num At Risk
232
num Events
40
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
22
num At Risk
228
num Events
25
group Id
EG001
num Affected
18
num At Risk
232
num Events
19
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
228
num Events
19
group Id
EG001
num Affected
8
num At Risk
232
num Events
11
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
17
num At Risk
228
num Events
22
group Id
EG001
num Affected
11
num At Risk
232
num Events
15
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
12
num At Risk
232
num Events
12
term
Headache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
2
num At Risk
232
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Anaemia macrocytic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Skin abrasion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Colorectal cancer

time Frame

116 months (duration from first patient enrolled to data cut-off for the final analysis)

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Preserved source evidence · Not medical advice