A clinical trial to compare efficacy and tolerability of Faslodex with Arimidex in patients with advanced breast cancer - FIRST

Study identifier:D6995C00006

ClinicalTrials.gov identifier:NCT00274469

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

Medical condition

Metastatic Breast Cancer

Phase

Phase 2

Healthy volunteers

Study drug

fulvestrant, anastrozole

Sex

Female

Actual Enrollment

205

Study type

Interventional

Age

45 Years - 100 Years

Date

Study Start Date: 06 Feb 2006

Primary Completion Date: 10 Jan 2008

Study Completion Date: 13 Jan 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2019 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Sofia, Bulgaria, 1527

Location

Research Site

Sofia, Bulgaria, 1784

Location

Research Site

Sofia, Bulgaria, 1233

Location

Research Site

Plovdiv, Bulgaria, 4000

Location

Research Site

Varna, Bulgaria, 9000

Location

Research Site

Shumen, Bulgaria, 9700

Location

Research Site

Veliko Tarnovo, Bulgaria, 5000

Location

Research Site

Blagoevgrad, Bulgaria, 2700

Arms	Assigned Interventions
Experimental: 1 Fulvestrant	Drug: fulvestrant 500 mg intramuscular injection Other Name: Faslodex Other Name: ZD9238
Active Comparator: 2 Anastrozole	Drug: anastrozole 1 mg oral tablet Other Name: Arimidex Other Name: ZD1033

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Postmenopausal women presenting with advanced breast cancer who had either never received endocrine therapy for advanced disease or had not received endocrine therapy in the previous 12 months in the adjuvant setting were recruited between 6th Feb 2006 and 11th July 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
28 of the 233 enrolled patients were not randomized to treatment groups for the following reasons - 20 patients were incorrectly enrolled (ie did not comply with inclusion / exclusion criteria), 1 died, 1 had an adverse event, 4 voluntarily discontinued, 2 patients were not randomized for other non-specified reasons.

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Participant Flow: Overall Study

	Fulvestrant 500 mg	Anastrozole 1 mg
STARTED	102^[1]	103^[2]
COMPLETED	23^[3]	10^[4]
NOT COMPLETED	79	93
Death	63	74
Did not consent to OS follow-up	16	19

[1]	Number of patients randomized
[2]	Number of patients randomized
[3]	Number of patients ongoing study treatment at data cut-off
[4]	Number of patients ongoing study treatment at data cut-off

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Baseline Measures

	Fulvestrant 500 mg	Anastrozole 1 mg	Total
Number of Participants [units: Participants]	102	103	205
Age Continuous [units: Years] Mean ± Standard Deviation	66.6 ± 9.0	67.6 ± 9.3	67.1 ± 9.1
Sex: Female, Male [units: ]
Female	102	103	205
Male	0	0	0

Outcome Measures

1. Primary Outcome Measure: Clinical Benefit Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]

Measure Type	Primary
Measure Name	Clinical Benefit Rate
Measure Description	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	102	103
Clinical Benefit Rate [units: Percentage of Participants]	72.5	67.0

Statistical Analysis 1 for Clinical Benefit Rate

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.386
Odds Ratio (OR)^[5]	1.302
95% Confidence Interval	( 0.717 to 2.380 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Null hypothesis: Fulvestrant has no difference with Anastrozole
[5]	Other relevant estimation information:
	OR>1 favours Fulvestrant

2. Secondary Outcome Measure: Objective Response Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]

Measure Type	Secondary
Measure Name	Objective Response Rate
Measure Description	For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable For Response Set

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	89	93
Objective Response Rate [units: Percentage of Participants]	36.0	35.5

Statistical Analysis 1 for Objective Response Rate

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.947
Odds Ratio (OR)^[5]	1.021
95% Confidence Interval	( 0.556 to 1.874 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	OR>1 favours Fulvestrant

3. Secondary Outcome Measure: Time to progression [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]

Measure Type	Secondary
Measure Name	Time to progression
Measure Description	Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.
Time Frame	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set.

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	102	103
Time to progression [units: Day] Median (Inter-Quartile Range)	NA (173 to NA) ^[1]	381 (168 to NA) ^[1]

Statistical Analysis 1 for Time to progression

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.0496
Hazard Ratio (HR)^[5]	0.6266
95% Confidence Interval	( 0.3929 to 0.9991 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

4. Secondary Outcome Measure: Time to treatment failure [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]

Measure Type	Secondary
Measure Name	Time to treatment failure
Measure Description	Time from randomization to treatment discontinuation
Time Frame	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set.

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	102	103
Time to treatment failure [units: Day] Median (Inter-Quartile Range)	536 (166 to 1303)	387 (169 to 838)

Statistical Analysis 1 for Time to treatment failure

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.05
Hazard Ratio (HR)^[5]	0.73
95% Confidence Interval	( 0.54 to 1.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

Statistical Analysis 2 for Time to treatment failure

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.04
Hazard Ratio (HR)^[5]	0.72
95% Confidence Interval	( 0.52 to 0.98 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Cox regression analysis of TTTF controlling for baseline covariates.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

5. Secondary Outcome Measure: Time to progression (investigator assessed) [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]

Measure Type	Secondary
Measure Name	Time to progression (investigator assessed)
Measure Description	Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.
Time Frame	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set.

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	102	103
Time to progression (investigator assessed) [units: Day] Median (Inter-Quartile Range)	712 (173 to 1331)	400 (168 to 908)

Statistical Analysis 1 for Time to progression (investigator assessed)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.01
Hazard Ratio (HR)^[5]	0.66
95% Confidence Interval	( 0.47 to 0.92 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

Statistical Analysis 2 for Time to progression (investigator assessed)

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.01
Hazard Ratio (HR)^[5]	0.64
95% Confidence Interval	( 0.46 to 0.90 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

6. Post-Hoc Outcome Measure: Overall Survival [ Time Frame: From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled. ]

Measure Type	Post-Hoc
Measure Name	Overall Survival
Measure Description	Time from randomization to death (any cause)
Time Frame	From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Measured Values

	Fulvestrant 500 mg	Anastrozole 1 mg
Number of Participants Analyzed [units:participants]	102	103
Overall Survival [units: Month] Median (Inter-Quartile Range)	54.1 (29.7 to NA) ^[1]	48.4 (28.6 to 78.5)

Statistical Analysis 1 for Overall Survival

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.041
Hazard Ratio (HR)^[5]	0.70
95% Confidence Interval	( 0.50 to 0.98 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Overall Survival

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.126
Hazard Ratio (HR)^[5]	0.76
95% Confidence Interval	( 0.54 to 1.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Cox regression analysis of OS controlling for baseline covariates
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	HR<1 favours Fulvestrant

Serious Adverse Events

Time Frame

Non-serious adverse events = randomisation upto the point of data cut off for the primary efficacy analysis. Serious adverse events = randomisation up to the point of data cut off for the 65% overall survival analysis.

Additional Description

First patient was enrolled on 6th Feb 2006. Non-serious AEs are reported from randomisation up to the data cut-off (DCO 10th Jan 2008) for the primary analysis (56 days after last injection and 30 days after last tablet). Serious AEs are reported from randomisation up to DCO for the 65% OS (15th July 2014). Note: All-Mortality is based on full population, while AEs and SAEs are based on safety population (1 less patient in Fulvestrant arm as it never received the randomised drug).

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Serious Adverse Events

Fulvestrant 500 mg

Anastrozole 1 mg

Total, serious adverse events

# participants affected / at risk

24/101 (23.76%)

22/103 (21.36%)

Cardiac disorders

ATRIAL FIBRILLATION¹,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Infections and infestations

BRONCHITIS¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

CHRONIC OBSTRUCTIVE PULMONARY DISEASE¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Psychiatric disorders

CONFUSIONAL STATE¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

DYSPNOEA¹,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

FALL¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

FEMUR FRACTURE¹,^†

# participants affected / at risk

1/101 (0.99%)

2/103 (1.94%)

# events

Gastrointestinal disorders

GASTRIC ULCER¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

GASTROENTERITIS VIRAL¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

HUMERUS FRACTURE¹,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

LACRIMAL DISORDER¹,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Blood and lymphatic system disorders

LYMPHADENOPATHY¹,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

NAUSEA¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Nervous system disorders

NEURALGIA¹,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Musculoskeletal and connective tissue disorders

OSTEOARTHRITIS¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

PLEURITIC PAIN¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

PNEUMONIA¹,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

RADIUS FRACTURE¹,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

TRANSIENT ISCHAEMIC ATTACK¹,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Gastrointestinal disorders

VOMITING¹,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Blood and lymphatic system disorders

FEBRILE NEUTROPENIA²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Cardiac disorders

ARRHYTHMIA²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Cardiac disorders

CARDIAC FAILURE²,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Cardiac disorders

CARDIAC FAILURE CONGESTIVE²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Cardiac disorders

CORONARY OSTIAL STENOSIS²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

BLINDNESS²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Gastrointestinal disorders

ANAL HAEMRROHAGE²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Gastrointestinal disorders

SUBILEUS²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

General disorders

ASTHENIA²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

DEATH²,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

General disorders

GENERAL PHYSICAL HEALTH DETERIORATION²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

ARTHRITIS BACTERIAL²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

EMPYEMA²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

URINARY TRACT INFECTION²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

LOWER RESPIRATORY TRACT INFECTION²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

FEMORAL NECK FRACTURE²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

HIP FRACTURE²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

RIB FRACTURE²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

ROAD TRAFFIC ACCIDENT²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

CACHEXIA²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Metabolism and nutrition disorders

DECREASED APPETITE²,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Metabolism and nutrition disorders

DEHYDRATION²,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Musculoskeletal and connective tissue disorders

BONE PAIN²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

COLON CANCER²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

LUNG CANCERMETASTATIC²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

METASTASES TO THORAX²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

SARCOMA²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

SQUAMOUS CELL CARCINOMA²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

TUMOUR HAEMORRAGE²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Nervous system disorders

CEREBROVASCULAR ACCIDENT²,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

SPINAL CORD COMPRESSION²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

PULMONARY EMBOLISM²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

ANGIOEDEMA²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Surgical and medical procedures

CHOLECYSTECTOMY²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Vascular disorders

HYPERTENSION²,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary, MedDRA

Other Adverse Events

Time Frame

Additional Description

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Fulvestrant 500 mg	Fulvestrant 500 mg
Anastrozole 1 mg	Anastrozole 1 mg

Other Adverse Events

Fulvestrant 500 mg

Anastrozole 1 mg

Total, other (not including serious) adverse events

# participants affected / at risk

71/101 (70.30%)

70/103 (67.96%)

Musculoskeletal and connective tissue disorders

ARTHRALGIA¹,^†

# participants affected / at risk

10/101 (9.90%)

8/103 (7.77%)

# events

Musculoskeletal and connective tissue disorders

BONE PAIN¹,^†

# participants affected / at risk

14/101 (13.86%)

10/103 (9.71%)

# events

Gastrointestinal disorders

CONSTIPATION¹,^†

# participants affected / at risk

10/101 (9.90%)

5/103 (4.85%)

# events

Respiratory, thoracic and mediastinal disorders

COUGH¹,^†

# participants affected / at risk

5/101 (4.95%)

8/103 (7.77%)

# events

Gastrointestinal disorders

DIARRHOEA¹,^†

# participants affected / at risk

6/101 (5.94%)

7/103 (6.80%)

# events

Nervous system disorders

DIZZINESS¹,^†

# participants affected / at risk

4/101 (3.96%)

6/103 (5.83%)

# events

Respiratory, thoracic and mediastinal disorders

DYSPNOEA¹,^†

# participants affected / at risk

7/101 (6.93%)

7/103 (6.80%)

# events

General disorders

FATIGUE¹,^†

# participants affected / at risk

1/101 (0.99%)

8/103 (7.77%)

# events

Nervous system disorders

HEADACHE¹,^†

# participants affected / at risk

4/101 (3.96%)

13/103 (12.62%)

# events

Vascular disorders

HOT FLUSH²,^†

# participants affected / at risk

8/101 (7.92%)

14/103 (13.59%)

# events

Vascular disorders

HYPERTENSION¹,^†

# participants affected / at risk

6/101 (5.94%)

2/103 (1.94%)

# events

Infections and infestations

INFLUENZA¹,^†

# participants affected / at risk

1/101 (0.99%)

6/103 (5.83%)

# events

General disorders

INJECTION SITE PAIN¹,^†

# participants affected / at risk

6/101 (5.94%)

0/103 (0.00%)

# events

Musculoskeletal and connective tissue disorders

MYALGIA¹,^†

# participants affected / at risk

3/101 (2.97%)

9/103 (8.74%)

# events

Gastrointestinal disorders

NAUSEA¹,^†

# participants affected / at risk

10/101 (9.90%)

7/103 (6.80%)

# events

Gastrointestinal disorders

VOMITING¹,^†

# participants affected / at risk

8/101 (7.92%)

3/103 (2.91%)

# events

General disorders

ASTHENIA³,^†

# participants affected / at risk

8/101 (7.92%)

8/103 (7.77%)

# events

Gastrointestinal disorders

DYSPEPSIA³,^†

# participants affected / at risk

2/101 (1.98%)

5/103 (4.85%)

# events

Gastrointestinal disorders

ABDOMINAL PAIN³,^†

# participants affected / at risk

2/101 (1.98%)

2/103 (1.94%)

# events

Gastrointestinal disorders

ABDOMINAL PAIN UPPER³,^†

# participants affected / at risk

2/101 (1.98%)

2/103 (1.94%)

# events

Gastrointestinal disorders

HIATUS HERNIA³,^†

# participants affected / at risk

2/101 (1.98%)

2/103 (1.94%)

# events

Gastrointestinal disorders

DRY MOUTH³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Gastrointestinal disorders

ANAL DISCOMFORT³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Gastrointestinal disorders

DIVERTICULUM INTESTINAL³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Gastrointestinal disorders

GASTROOESOPHAGEAL REFLUX DISEASE³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Gastrointestinal disorders

STOMATITIS³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Gastrointestinal disorders

ABDOMINAL DISTENSION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

ABDOMINAL PAIN LOWER³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

FLATULENCE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Gastrointestinal disorders

GASTRODUODENITIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Gastrointestinal disorders

GASTROINTESTINAL PAIN³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

HAEMATEMESIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

HAEMORRHOIDAL HAEMORRHAGE³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

HAEMORRHOIDS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

PROCTITIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Gastrointestinal disorders

RETCHING³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

OEDEMA PERIPHERAL³,^†

# participants affected / at risk

0/101 (0.00%)

4/103 (3.88%)

# events

General disorders

PYREXIA³,^†

# participants affected / at risk

2/101 (1.98%)

2/103 (1.94%)

# events

General disorders

INFLUENZA LIKE ILLNESS³,^†

# participants affected / at risk

3/101 (2.97%)

0/103 (0.00%)

# events

General disorders

INJECTION SITE HAEMATOMA³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

INJECTION SITE HAEMORRHAGE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

INJECTION SITE PRURITUS³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

General disorders

APPLICATION SITE PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

GENERAL PHYSICAL HEALTH DETERIORATION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

CHILLS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

GAIT DISTURBANCE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

INJECTION SITE NODULE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

General disorders

IRRITABILITY³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

General disorders

NON-CARDIAC CHEST PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Nervous system disorders

NEURALGIA³,^†

# participants affected / at risk

1/101 (0.99%)

2/103 (1.94%)

# events

Nervous system disorders

DYSGEUSIA³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Nervous system disorders

LETHARGY³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Nervous system disorders

SOMNOLENCE³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Nervous system disorders

CEREBRAL ISCHAEMIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

DIABETIC NEUROPATHY³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Nervous system disorders

DISTURBANCE IN ATTENTION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

MEMORY IMPAIRMENT³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

PARKINSON'S DISEASE³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

PAROSMIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

SYNCOPE³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Nervous system disorders

VITH NERVE PARALYSIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

URINARY TRACT INFECTION³,^†

# participants affected / at risk

4/101 (3.96%)

1/103 (0.97%)

# events

Infections and infestations

BRONCHITIS³,^†

# participants affected / at risk

3/101 (2.97%)

3/103 (2.91%)

# events

Infections and infestations

UPPER RESPIRATORY TRACT INFECTION³,^†

# participants affected / at risk

3/101 (2.97%)

3/103 (2.91%)

# events

Infections and infestations

LOWER RESPIRATORY TRACT INFECTION³,^†

# participants affected / at risk

1/101 (0.99%)

3/103 (2.91%)

# events

Infections and infestations

CYSTITIS³,^†

# participants affected / at risk

3/101 (2.97%)

1/103 (0.97%)

# events

Infections and infestations

HERPES ZOSTER³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Infections and infestations

ORAL CANDIDIASIS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Infections and infestations

SINUSITIS³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Infections and infestations

TONSILLITIS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Infections and infestations

VIRAL UPPER RESPIRATORY TRACT INFECTION³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Infections and infestations

WOUND INFECTION STAPHYLOCOCCAL³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Infections and infestations

ACARIASIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

BACTERIAL INFECTION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

CANDIDIASIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

FUNGAL INFECTION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

IMPETIGO³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

NASOPHARYNGITIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

OSTEOMYELITIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

PNEUMONIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Infections and infestations

RESPIRATORY TRACT INFECTION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

RHINITIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

VIRAL INFECTION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Infections and infestations

WOUND INFECTION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

DYSPHONIA³,^†

# participants affected / at risk

1/101 (0.99%)

5/103 (4.85%)

# events

Respiratory, thoracic and mediastinal disorders

PHARYNGOLARYNGEAL PAIN³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

EPISTAXIS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

NASAL CONGESTION³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

ALLERGIC SINUSITIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

BRONCHOSPASM³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

DYSPNOEA EXERTIONAL³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

LARYNGEAL DISORDER³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

LUNG INFILTRATION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

NASAL DRYNESS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

PLEURAL EFFUSION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Respiratory, thoracic and mediastinal disorders

RALES³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

UPPER RESPIRATORY TRACT INFLAMMATION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Vascular disorders

HAEMATOMA³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Vascular disorders

HYPERAEMIA³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Vascular disorders

PHLEBITIS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Vascular disorders

HYPOTENSION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

ALOPECIA³,^†

# participants affected / at risk

3/101 (2.97%)

2/103 (1.94%)

# events

Skin and subcutaneous tissue disorders

RASH³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

HYPERHIDROSIS³,^†

# participants affected / at risk

4/101 (3.96%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

DERMATITIS CONTACT³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

PRURITUS³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

DRY SKIN³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

NIGHT SWEATS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

COLD SWEAT³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

DERMATITIS ALLERGIC³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

ECZEMA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Skin and subcutaneous tissue disorders

SCAR³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Skin and subcutaneous tissue disorders

SUBCUTANEOUS NODULE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Psychiatric disorders

DEPRESSION³,^†

# participants affected / at risk

2/101 (1.98%)

4/103 (3.88%)

# events

Psychiatric disorders

ANXIETY³,^†

# participants affected / at risk

3/101 (2.97%)

2/103 (1.94%)

# events

Psychiatric disorders

INSOMNIA³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Psychiatric disorders

DEPRESSED MOOD³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Psychiatric disorders

CRYING³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Psychiatric disorders

LIBIDO DECREASED³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Psychiatric disorders

NEUROSIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

ANOREXIA³,^†

# participants affected / at risk

2/101 (1.98%)

3/103 (2.91%)

# events

Metabolism and nutrition disorders

DECREASED APPETITE³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

DIABETES MELLITUS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

FLUID RETENTION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Metabolism and nutrition disorders

HYPERGLYCAEMIA³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Metabolism and nutrition disorders

HYPERURICAEMIA³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Metabolism and nutrition disorders

HYPOALBUMINAEMIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

HYPOCALCAEMIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Metabolism and nutrition disorders

VITAMIN D DEFICIENCY³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

CONTUSION³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

THERMAL BURN³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

ANAEMIA POSTOPERATIVE³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

CONTRAST MEDIA REACTION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

FALL³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

FEMUR FRACTURE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

JOINT INJURY³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

LACERATION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

POST PROCEDURAL COMPLICATION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

PUBIC RAMI FRACTURE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

RADIATION SKIN INJURY³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Injury, poisoning and procedural complications

RIB FRACTURE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Injury, poisoning and procedural complications

SKELETAL INJURY³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Reproductive system and breast disorders

BREAST PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

2/103 (1.94%)

# events

Reproductive system and breast disorders

VULVOVAGINAL DRYNESS³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Reproductive system and breast disorders

BREAST HAEMORRHAGE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Reproductive system and breast disorders

BREAST TENDERNESS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Reproductive system and breast disorders

CERVICAL POLYP³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Reproductive system and breast disorders

DYSPAREUNIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Reproductive system and breast disorders

GENITAL DISCHARGE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Reproductive system and breast disorders

GENITAL RASH³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Reproductive system and breast disorders

METRORRHAGIA³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Investigations

ALANINE AMINOTRANSFERASE INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Investigations

BLOOD PRESSURE INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

2/103 (1.94%)

# events

Investigations

BLOOD ALKALINE PHOSPHATASE INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Investigations

GAMMA-GLUTAMYLTRANSFERASE INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Investigations

HEPATIC ENZYME INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Investigations

WEIGHT INCREASED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Eye disorders

ACCOMMODATION DISORDER³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

CONJUNCTIVAL DISORDER³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

DIPLOPIA³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Eye disorders

ERYTHEMA OF EYELID³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Eye disorders

EXOPHTHALMOS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Eye disorders

EYE PAIN³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

EYELID PTOSIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Eye disorders

MYOPIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Eye disorders

VISUAL ACUITY REDUCED³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Ear and labyrinth disorders

VERTIGO³,^†

# participants affected / at risk

1/101 (0.99%)

3/103 (2.91%)

# events

Ear and labyrinth disorders

TINNITUS³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Ear and labyrinth disorders

EAR PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Renal and urinary disorders

DYSURIA³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Renal and urinary disorders

URINE ODOUR ABNORMAL³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Renal and urinary disorders

HAEMATURIA³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Renal and urinary disorders

NEPHROLITHIASIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Blood and lymphatic system disorders

ANAEMIA³,^†

# participants affected / at risk

2/101 (1.98%)

1/103 (0.97%)

# events

Blood and lymphatic system disorders

LYMPHADENOPATHY³,^†

# participants affected / at risk

2/101 (1.98%)

0/103 (0.00%)

# events

Hepatobiliary disorders

HEPATIC PAIN³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Hepatobiliary disorders

CHOLELITHIASIS³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Hepatobiliary disorders

HEPATIC FUNCTION ABNORMAL³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Hepatobiliary disorders

LIVER TENDERNESS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Immune system disorders

CONTRAST MEDIA ALLERGY³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Immune system disorders

SEASONAL ALLERGY³,^†

# participants affected / at risk

0/101 (0.00%)

2/103 (1.94%)

# events

Immune system disorders

HYPERSENSITIVITY³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

CANCER PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

INFECTED NEOPLASM³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

METASTASES TO CENTRAL NERVOUS SYSTEM³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

TUMOUR PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Cardiac disorders

ATRIAL FIBRILLATION³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Cardiac disorders

LEFT VENTRICULAR DYSFUNCTION³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Cardiac disorders

PALPITATIONS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Endocrine disorders

GOITRE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Musculoskeletal and connective tissue disorders

BACK PAIN³,^†

# participants affected / at risk

4/101 (3.96%)

3/103 (2.91%)

# events

Musculoskeletal and connective tissue disorders

MUSCULOSKELETAL PAIN³,^†

# participants affected / at risk

2/101 (1.98%)

2/103 (1.94%)

# events

Musculoskeletal and connective tissue disorders

MUSCLE SPASMS³,^†

# participants affected / at risk

1/101 (0.99%)

2/103 (1.94%)

# events

Musculoskeletal and connective tissue disorders

PAIN IN EXTREMITY³,^†

# participants affected / at risk

0/101 (0.00%)

3/103 (2.91%)

# events

Musculoskeletal and connective tissue disorders

JOINT STIFFNESS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Musculoskeletal and connective tissue disorders

MUSCULOSKELETAL CHEST PAIN³,^†

# participants affected / at risk

0/101 (0.00%)

3/103 (2.91%)

# events

Musculoskeletal and connective tissue disorders

OSTEOARTHRITIS³,^†

# participants affected / at risk

1/101 (0.99%)

1/103 (0.97%)

# events

Musculoskeletal and connective tissue disorders

BURSITIS³,^†

# participants affected / at risk

0/101 (0.00%)

1/103 (0.97%)

# events

Musculoskeletal and connective tissue disorders

GROIN PAIN³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Musculoskeletal and connective tissue disorders

MUSCLE CONTRACTURE³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

Musculoskeletal and connective tissue disorders

SYMPATHETIC POSTERIOR CERVICAL SYNDROME³,^†

# participants affected / at risk

1/101 (0.99%)

0/103 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary, MedDRA 10.
3	Term from vocabulary, MedDRA

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One patient in the ITT population was randomized to Fulvestrant 500 but did not receive drug and was excluded from the safety population. Hence, the safety population for Fulvestrant contained 101 patients.

Results Point of Contact

Name/Title:	Jasmine Lichfield
Organization:	AstraZeneca
Phone	07585404954
E-mail:	[email protected]

Documents available

CSR-D6995C00006.pdf
Download
D6995C00006FIRSToverall_survivalRevisedCSP_4_10_December_2014_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Locator Service

877-400-4656

astrazeneca@emergingmed.com

Investigators

Principal Investigator

AstraZeneca Faslodex Medical Science Director

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR-D6995C00006.pdf

D6995C00006FIRSToverall_survivalRevisedCSP_4_10_December_2014_Redacted

Trial Results Summaries