NCT00099437 · ADVERSE EVENTS

Adverse events

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. · Source last updated 2026-06-11

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: SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
Other-event reporting threshold: 5%

1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Fulvestrant 250 mg Fulvestrant 250 mg Intramuscular Injection every 28 days	27 / 374	235 / 374	Not reported / Not reported
Fulvestrant 500 mg Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14	35 / 361	241 / 361	Not reported / Not reported

Group identifiers: EG000: Fulvestrant 250 mg · EG001: Fulvestrant 500 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 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
3
num At Risk
361
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Cardiopulmonary Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
2
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Myocardial Ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
3
num At Risk
361
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Duodenal Ulcer Perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Peritonitis

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 11.1
stats
group Id
EG000
num Affected
51
num At Risk
374
group Id
EG001
num Affected
35
num At Risk
361
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
20
num At Risk
374
group Id
EG001
num Affected
21
num At Risk
361
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
34
num At Risk
374
group Id
EG001
num Affected
42
num At Risk
361
term
Injection Site Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
24
num At Risk
374
group Id
EG001
num Affected
27
num At Risk
361
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
23
num At Risk
374
group Id
EG001
num Affected
21
num At Risk
361
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
14
num At Risk
374
group Id
EG001
num Affected
22
num At Risk
361
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
40
num At Risk
374
group Id
EG001
num Affected
26
num At Risk
361
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
28
num At Risk
374
group Id
EG001
num Affected
34
num At Risk
361
term
Bone Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
29
num At Risk
374
group Id
EG001
num Affected
29
num At Risk
361
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
26
num At Risk
374
group Id
EG001
num Affected
25
num At Risk
361
term
Pain In Extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
12
num At Risk
374
group Id
EG001
num Affected
20
num At Risk
361
term
Musculoskeletal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
25
num At Risk
374
group Id
EG001
num Affected
28
num At Risk
361
term
Headache

Complete source fields

description

1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.

event Groups

description
Fulvestrant 250 mg Intramuscular Injection every 28 days
id
EG000
other Num Affected
235
other Num At Risk
374
serious Num Affected
27
serious Num At Risk
374
title
Fulvestrant 250 mg
description
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
id
EG001
other Num Affected
241
other Num At Risk
361
serious Num Affected
35
serious Num At Risk
361
title
Fulvestrant 500 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
51
num At Risk
374
group Id
EG001
num Affected
35
num At Risk
361
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
20
num At Risk
374
group Id
EG001
num Affected
21
num At Risk
361
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
34
num At Risk
374
group Id
EG001
num Affected
42
num At Risk
361
term
Injection Site Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
24
num At Risk
374
group Id
EG001
num Affected
27
num At Risk
361
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
23
num At Risk
374
group Id
EG001
num Affected
21
num At Risk
361
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
14
num At Risk
374
group Id
EG001
num Affected
22
num At Risk
361
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
40
num At Risk
374
group Id
EG001
num Affected
26
num At Risk
361
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
28
num At Risk
374
group Id
EG001
num Affected
34
num At Risk
361
term
Bone Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
29
num At Risk
374
group Id
EG001
num Affected
29
num At Risk
361
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
26
num At Risk
374
group Id
EG001
num Affected
25
num At Risk
361
term
Pain In Extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
12
num At Risk
374
group Id
EG001
num Affected
20
num At Risk
361
term
Musculoskeletal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
25
num At Risk
374
group Id
EG001
num Affected
28
num At Risk
361
term
Headache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
3
num At Risk
361
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Cardiopulmonary Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
2
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
0
num At Risk
361
term
Myocardial Ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
3
num At Risk
361
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Duodenal Ulcer Perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
374
group Id
EG001
num Affected
1
num At Risk
361
term
Peritonitis

time Frame

SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009

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Preserved source evidence · Not medical advice