Trial Outcomes & Findings for Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole (NCT NCT00543127)

NCT ID: NCT00543127

Last Updated: 2023-03-10

Results Overview

Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years. DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 870 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2023-03-10

Participant Flow

870 patients were recruited, from them, 437 were randomized to Anastrozole (A) and 433 to A plus Fulvestrant (F), but 18 patients (3 in A arm and 15 in arm A+F) never received treatment.

Participant milestones

Measure	Fulvestrant + Anastrozole Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Overall Study STARTED	433	437
Overall Study COMPLETED	303	350
Overall Study NOT COMPLETED	130	87

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

Baseline characteristics by cohort

Measure	Fulvestrant + Anastrozole n=433 Participants Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 Participants Anastrozole: 1 mg oral Anastrozole per day during 5 years.	Total n=870 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	433 Participants n=5 Participants	437 Participants n=7 Participants	870 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Breast Surgery Conservative	303 Participants n=5 Participants	310 Participants n=7 Participants	613 Participants n=5 Participants
Breast Surgery Mastectomy	130 Participants n=5 Participants	127 Participants n=7 Participants	257 Participants n=5 Participants
Axillary surgery Axillary dissection	258 Participants n=5 Participants	281 Participants n=7 Participants	539 Participants n=5 Participants
Axillary surgery Sentinel Node Biopsy	174 Participants n=5 Participants	155 Participants n=7 Participants	329 Participants n=5 Participants
Axillary surgery Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Previous chemotherapy Adjuvant	256 Participants n=5 Participants	261 Participants n=7 Participants	517 Participants n=5 Participants
Previous chemotherapy Neoadjuvant	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Previous chemotherapy Neoadjuvant + Adjuvant	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Previous chemotherapy None	137 Participants n=5 Participants	140 Participants n=7 Participants	277 Participants n=5 Participants
Previous radiotherapy YES	348 Participants n=5 Participants	347 Participants n=7 Participants	695 Participants n=5 Participants
Previous radiotherapy NO	85 Participants n=5 Participants	90 Participants n=7 Participants	175 Participants n=5 Participants
Histopathologic type Invasive Ductal Carcinoma	337 Participants n=5 Participants	346 Participants n=7 Participants	683 Participants n=5 Participants
Histopathologic type Invasive Lobular Carcinoma	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
Histopathologic type Other	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Histologic grade Grade 1	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants
Histologic grade Grade 2	216 Participants n=5 Participants	235 Participants n=7 Participants	451 Participants n=5 Participants
Histologic grade Grade 3	94 Participants n=5 Participants	83 Participants n=7 Participants	177 Participants n=5 Participants
Histologic grade Grade X	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Tumor size	2 cm n=5 Participants	2 cm n=7 Participants	2 cm n=5 Participants
Final diagnosis tumor size T1	220 Participants n=5 Participants	243 Participants n=7 Participants	463 Participants n=5 Participants
Final diagnosis tumor size T2	189 Participants n=5 Participants	179 Participants n=7 Participants	368 Participants n=5 Participants
Final diagnosis tumor size T3-T4	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Final diagnosis tumor size TX	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Nodal status N0	214 Participants n=5 Participants	200 Participants n=7 Participants	414 Participants n=5 Participants
Nodal status N1	157 Participants n=5 Participants	164 Participants n=7 Participants	321 Participants n=5 Participants
Nodal status N2	42 Participants n=5 Participants	52 Participants n=7 Participants	94 Participants n=5 Participants
Nodal status N3	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Nodal status NX	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Primary statistical analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients

Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

Outcome measures

Measure	Fulvestrant + Anastrozole n=433 Participants Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 Participants Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Disease Free Survival (DFS) Events	49 Participants	62 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients.

BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.

BCsS event is defined as the death from breast cancer.

Outcome measures

Measure	Fulvestrant + Anastrozole n=433 Participants Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 Participants Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Breast Cancer Specific Survival (BCsS) Events	17 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Statistical analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients.

OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

OS event is defined as the death from any cause.

Outcome measures

Measure	Fulvestrant + Anastrozole n=433 Participants Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 Participants Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Overall Survival (OS) Event	28 Participants	34 Participants

SECONDARY outcome

Timeframe: Up to 5 years

TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause).

Outcome measures

Measure	Fulvestrant + Anastrozole n=433 Participants Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 Participants Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Time to Recurrence (TR) Event	36 Participants	46 Participants

Adverse Events

Fulvestrant + Anastrozole

Serious events: 40 serious events

Other events: 192 other events

Deaths: 0 deaths

Anastrozole

Serious events: 61 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fulvestrant + Anastrozole n=415 participants at risk Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 participants at risk Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hemoglobin	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders chronic lymphocytic leukemia	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders lymphoblastic leukemia	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Conduction abnormality/atrioventricular heart block - av block-second degree mobitz type ii	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Supraventricular and nodal arrhythmia - atrial fibrillation	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Supraventricular and nodal arrhythmia - sinus tachycardia	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Cardiac ischemia/infarction	0.48% 2/415 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Angor	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders dilated cardiomyopathy	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Pericarditis	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Cardiac disorders Valvular heart disease	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.46% 2/437 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Skin and subcutaneous tissue disorders Induration/fibrosis (skin and subcutaneous tissue)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Skin and subcutaneous tissue disorders melanoma	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Skin and subcutaneous tissue disorders squamous cell carcinoma	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Skin and subcutaneous tissue disorders t-cell lymphoma	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Endocrine disorders goitre	0.48% 2/415 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Colitis	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Diarrhea	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Gastritis	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Ileus, gi (functional obstruction of bowel, i.e., neuroconstipation)	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Nausea	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Colon cancer	0.72% 3/415 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.69% 3/437 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Inguinal Hernia	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Rectum cancer	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Transverse colon adenocarcinoma	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Perforation, gi - appendix	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Ulcer, gi - duodenum	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Vomiting	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hematoma	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hemorrhage, CNS	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hemorrhage, gi - colon	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hemorrhage, gi - stomach	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Blood and lymphatic system disorders Hemorrhage/bleeding associated with surgery, intra-operative or postoperative	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders Cholecystitis	0.48% 2/415 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders acute hepatitis	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders cholelithiasis	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.69% 3/437 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders pancreas cancer	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Hepatobiliary disorders Pancreatitis	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils (anc <1.0 x 109	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils dermatology/skin skin (cellulitis)	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory bronchus	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory lung (pneumonia)	0.72% 3/415 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory upper airway nos	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - sexual/reproductive function vagina and vulv	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with unknown ANC - cardiovascular heart (endocarditis)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with unknown ANC - gastrointestinal appendix	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with unknown ANC - gastrointestinal dental-tooth	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with unknown ANC - pulmonary/upper respiratory lung (pneumonia)	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.46% 2/437 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with unknown ANC - renal/genitourinary urinary tract nos	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Fracture	0.72% 3/415 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	1.1% 5/437 • Number of events 5 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders arthrosis	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Other: tendon rupture	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Nervous system disorders CNS cerebrovascular ischemia	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.92% 4/437 • Number of events 4 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Nervous system disorders Neuropathy: craneal - cn vi downward, inward movement of eye	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Nervous system disorders glioblastoma multiforme	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Nervous system disorders Meningioma	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Social circumstances Traffic accident	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Gastrointestinal abdomen nos pain	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.46% 2/437 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal back pain	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal bone pain	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal joint pain	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal neck pain	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory chest/thorax nos pain	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Lung cancer	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Renal and urinary disorders Cystocele	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Renal and urinary disorders Nephrolithiasis	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Renal and urinary disorders Renal failure	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.46% 2/437 • Number of events 2 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Renal and urinary disorders Secondary malignancy - possiby related to cancer treatment, specify: kidney cancer	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Secondary malignancy - possiby related to cancer treatment, specify: uterine cervix cancer	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Breast cancer	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Breast nodule	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Endometrial adenocarcinoma	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Microcalcification in breast	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Reproductive system and breast disorders Uterine polyp	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
General disorders Flu-like syndrome	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Vascular disorders Thrombosis/embolism (vascular access-related)	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.69% 3/437 • Number of events 3 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Gastrointestinal disorders Gastric difuse	0.24% 1/415 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.00% 0/437 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - renal/genitourinary kidney	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Infections and infestations Infection with normal ANC or grade 1 or 2 neutrophils - renal/genitourinary urinary tract nos	0.00% 0/415 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	0.23% 1/437 • Number of events 1 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.

Other adverse events

Measure	Fulvestrant + Anastrozole n=415 participants at risk Fulvestrant + Anastrozole: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.	Anastrozole n=437 participants at risk Anastrozole: 1 mg oral Anastrozole per day during 5 years.
Cardiac disorders Hypertension	9.9% 41/415 • Number of events 41 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	13.3% 58/437 • Number of events 58 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
General disorders Fatigue (asthenia, lethargy, malaise)	11.8% 49/415 • Number of events 49 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	5.3% 23/437 • Number of events 23 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
General disorders Weight gain	9.4% 39/415 • Number of events 39 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	7.1% 31/437 • Number of events 31 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
General disorders Weight loss	8.9% 37/415 • Number of events 37 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	9.4% 41/437 • Number of events 41 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Endocrine disorders Hot flashes/flushes	5.5% 23/415 • Number of events 23 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	4.1% 18/437 • Number of events 18 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Metabolism and nutrition disorders Cholesterol, serum-high (hypercholesterolemia)	5.1% 21/415 • Number of events 21 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	5.3% 23/437 • Number of events 23 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Metabolism and nutrition disorders LDL-cholesterol high	5.3% 22/415 • Number of events 22 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	9.4% 41/437 • Number of events 41 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal bone pain	9.4% 39/415 • Number of events 39 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	7.8% 34/437 • Number of events 34 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.
Musculoskeletal and connective tissue disorders Musculoskeletal joint pain	20.0% 83/415 • Number of events 83 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.	18.5% 81/437 • Number of events 81 • Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient. These Adverse Events are by patient (not per cycle). Only grades 2, 3 and 4 are specified.

Additional Information

Dr. Miguel Martin

Department of Medical Oncology, Hospital Universitario Gregorio Marañón

Email: miguel.martin@salud.madrid.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place