Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002371-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fulvestrant 500 mg |
|
| 2 | Experimental | Fulvestrant 250 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | intramuscular injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression). | RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR. | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Faslodex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Casa Grande | Arizona | 85122 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29522361 | Derived | Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9. |
| Label | URL |
|---|---|
| CSP-D6997C00002.PDF | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant 250 mg | Fulvestrant 250 mg Intramuscular Injection every 28 days |
| FG001 | Fulvestrant 500 mg | Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinical Benefit Rate (CBR) | A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB. | Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
| Duration of Response (DoR) | Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR) | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
| Duration of Clinical Benefit (DoCB) | Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
| Overall Survival (OS) | Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths ) | Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months) |
| Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study | Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients. | TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months) |
| Overall Survival (OS) - Follow-up | Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths) | Median time (in months) from randomisation until death (from any cause),up to 80 months |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Research Site | New Britain | Connecticut | 06052 | United States |
| Research Site | Crystal River | Florida | 34429 | United States |
| Research Site | Fort Lauderdale | Florida | 33308 | United States |
| Research Site | Urbana | Illinois | 61801 | United States |
| Research Site | Rosedale | Maryland | 21237 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | Kansas City | Missouri | 64131 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Voorhees Township | New Jersey | 08043 | United States |
| Research Site | Greenville | North Carolina | 27858 | United States |
| Research Site | Pasadena | Texas | 77504 | United States |
| Research Site | West Bend | Wisconsin | 53095 | United States |
| Research Site | Brasschaat | 2930 | Belgium |
| Research Site | Brussels | 1070 | Belgium |
| Research Site | Brussels | 1090 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Hasselt | 3500 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Turnhout | 2300 | Belgium |
| Research Site | Barretos | 14784-400 | Brazil |
| Research Site | Londrina | 86010-640 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Recife | 50670-420 | Brazil |
| Research Site | Salvador | 40170-070 | Brazil |
| Research Site | São Paulo | 04039-001 | Brazil |
| Research Site | Antofagasta | 1240000 | Chile |
| Research Site | Santiago | 8380455 | Chile |
| Research Site | Santiago | Chile |
| Research Site | Bogotá | Colombia |
| Research Site | Cali | Colombia |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | České Budějovice | 370 87 | Czechia |
| Research Site | Pardubice | 520 03 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Prague | 128 08 | Czechia |
| Research Site | Prague | 180 00 | Czechia |
| Research Site | Tábor | 390 03 | Czechia |
| Research Site | V Uvalu 84 | 150 06 | Czechia |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Székesfehérvár | 8000 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Ansārinagar | 110 029 | India |
| Research Site | Bhopal | 462001 | India |
| Research Site | Hyderabad | 500082 | India |
| Research Site | Jaipur | 302013 | India |
| Research Site | Kolkata | 700054 | India |
| Research Site | Manipal | 576 104 | India |
| Research Site | Marg Jaipur | 302004 | India |
| Research Site | Mumbai | 400012 | India |
| Research Site | Pune | 411001 | India |
| Research Site | Trivandrum | 2417 | India |
| Research Site | Vellore | 632004 | India |
| Research Site | Aviano | 33081 | Italy |
| Research Site | Bergamo | 24128 | Italy |
| Research Site | Carpi | 41012 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Prato | 59100 | Italy |
| Research Site | Reggio Emilia | 42100 | Italy |
| Research Site | Varese | 21100 | Italy |
| Research Site | Floriana | VLT 14 | Malta |
| Research Site | Mexico City | 06720 | Mexico |
| Research Site | México | 01090 | Mexico |
| Research Site | México | 14140 | Mexico |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Lodz | 90-553 | Poland |
| Research Site | Poznan | 61-878 | Poland |
| Research Site | Ivanovo | 153040 | Russia |
| Research Site | Kazan, Tatarstan | 420029 | Russia |
| Research Site | Kazan, Tatarstan | 420111 | Russia |
| Research Site | Krasnodar | 350040 | Russia |
| Research Site | Lipetsk | 398005 | Russia |
| Research Site | Moscow | 107005 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Moscow | 121356 | Russia |
| Research Site | Moscow | 59401 | Russia |
| Research Site | Nizhny Novgorod | 603081 | Russia |
| Research Site | Obninsk | 249020 | Russia |
| Research Site | Ryazan | 390046 | Russia |
| Research Site | Saint Petersburg | 191014 | Russia |
| Research Site | Saint Petersburg | 197089 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Yaroslavl | 150054 | Russia |
| Research Site | Bardejov | 08501 | Slovakia |
| Research Site | Bratislava | 812 50 | Slovakia |
| Research Site | Nitra | 949 01 | Slovakia |
| Research Site | Trnava | 917 75 | Slovakia |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Oviedo | 33011 | Spain |
| Research Site | Salamanca | 37007 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Cherkasy | 18009 | Ukraine |
| Research Site | Dnipro | 49102 | Ukraine |
| Research Site | Donetsk | 83092 | Ukraine |
| Research Site | Kyiv | 03022 | Ukraine |
| Research Site | Lviv | 79031 | Ukraine |
| Research Site | Sumy | 40022 | Ukraine |
| Research Site | Ternopil | 46023 | Ukraine |
| Research Site | Uzhhorod | 88000 | Ukraine |
| Research Site | Caracas | 1010 | Venezuela |
| Research Site | Caracas | 1053 | Venezuela |
| Research Site | Caracas | 1060 | Venezuela |
| D6997C00002 Study Report Synopsis | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant 250 mg | Fulvestrant 250 mg Intramuscular Injection every 28 days |
| BG001 | Fulvestrant 500 mg | Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression (TTP) | Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression). | Posted | Median | Full Range | months | RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR. | All patients with measurable disease at baseline. | Posted | Number | Percentage of patients | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB. | Posted | Number | Percentage of patients | Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR) | Posted | Median | Full Range | Time (in months) | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Clinical Benefit (DoCB) | Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks | Posted | Median | Full Range | Time (in months) | RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths ) | All patients with measurable disease at baseline. | Posted | Median | Full Range | Time (in months) | Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study | Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients. | Posted | Mean | Standard Deviation | Scores on a scale | TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Follow-up | Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths) | All randomised patients | Posted | Median | Full Range | months | Median time (in months) from randomisation until death (from any cause),up to 80 months |
|
|
SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fulvestrant 250 mg | Fulvestrant 250 mg Intramuscular Injection every 28 days | 27 | 374 | 235 | 374 | ||
| EG001 | Fulvestrant 500 mg | Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14 | 35 | 361 | 241 | 361 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Benign Mediastinal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Intestinal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Meningorrhagia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arterial Thrombosis Limb | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Iliac Artery Embolism | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| INFECTIOUS PERITONITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Injection Site Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|