Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 12:01 PM
Study NCT ID:
NCT01050634
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2010-01-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C056516', 'term': 'exemestane'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Observational', 'otherNumAtRisk': 924, 'otherNumAffected': 82, 'seriousNumAtRisk': 924, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthritis reactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nodal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thinking abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Menopausal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Menopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tumour invasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 924, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '860', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'classes': [{'title': 'Physical Well-Being (n=773)', 'categories': [{'measurements': [{'value': '-5.82', 'spread': '23.58', 'groupId': 'OG000'}]}]}, {'title': 'Mood (n=775)', 'categories': [{'measurements': [{'value': '-8.37', 'spread': '21.88', 'groupId': 'OG000'}]}]}, {'title': 'Tiredness (n=774)', 'categories': [{'measurements': [{'value': '-8.22', 'spread': '23.20', 'groupId': 'OG000'}]}]}, {'title': 'Appetite (n=776)', 'categories': [{'measurements': [{'value': '-7.04', 'spread': '21.35', 'groupId': 'OG000'}]}]}, {'title': 'Hot Flushes (n=772)', 'categories': [{'measurements': [{'value': '-5.98', 'spread': '24.65', 'groupId': 'OG000'}]}]}, {'title': 'Feeling Sick (Nausea/Vomiting) (n=774)', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '15.52', 'groupId': 'OG000'}]}]}, {'title': 'Effort to Cope with Illness (n=773)', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '22.95', 'groupId': 'OG000'}]}]}, {'title': 'Feel Supported by People Close to You (n=774)', 'categories': [{'measurements': [{'value': '-2.09', 'spread': '18.23', 'groupId': 'OG000'}]}]}, {'title': 'Operation Restricts Use of Arm (n=771)', 'categories': [{'measurements': [{'value': '-4.96', 'spread': '18.64', 'groupId': 'OG000'}]}]}, {'title': 'Imagine Rest of Life in Current Condition (n=767)', 'categories': [{'measurements': [{'value': '-5.42', 'spread': '17.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': "10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Thickness of Endometrium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Ultrasound measurement. New derived variable for normalization of endometrium thickness:\n\n1 = Endometrium thickness \\<=5mm 0 = Endometrium thickness \\>5mm', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '860', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'classes': [{'title': 'Being Irritable (n=771)', 'categories': [{'measurements': [{'value': '-5.22', 'spread': '20.58', 'groupId': 'OG000'}]}]}, {'title': 'Sweats (Including Night Sweats) (n=771)', 'categories': [{'measurements': [{'value': '-7.44', 'spread': '23.63', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal Discharge (n=766)', 'categories': [{'measurements': [{'value': '-3.45', 'spread': '17.67', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal Dryness (n=765)', 'categories': [{'measurements': [{'value': '-4.98', 'spread': '26.44', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal Itching/Vaginal Irritation (n=765)', 'categories': [{'measurements': [{'value': '-1.70', 'spread': '20.89', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Disturbance (n=769)', 'categories': [{'measurements': [{'value': '-5.35', 'spread': '22.48', 'groupId': 'OG000'}]}]}, {'title': 'Feeling Dizzy (n=768)', 'categories': [{'measurements': [{'value': '-2.42', 'spread': '19.28', 'groupId': 'OG000'}]}]}, {'title': 'Headaches (n=771)', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '18.97', 'groupId': 'OG000'}]}]}, {'title': 'Bone or Joint Pain (n=772)', 'categories': [{'measurements': [{'value': '1.67', 'spread': '26.49', 'groupId': 'OG000'}]}]}, {'title': 'Troubled by Weight Gain (n=770)', 'categories': [{'measurements': [{'value': '-5.39', 'spread': '21.69', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Sexual Interest (n=741)', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '25.64', 'groupId': 'OG000'}]}]}, {'title': 'Overall Bothered by Treatment (n=718)', 'categories': [{'measurements': [{'value': '-6.59', 'spread': '22.48', 'groupId': 'OG000'}]}]}, {'title': 'Had Difficulties Becoming Aroused? (n=345)', 'categories': [{'measurements': [{'value': '-3.37', 'spread': '19.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': "Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused - all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'classes': [{'title': 'Mental Summary Scale', 'categories': [{'measurements': [{'value': '2.93', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Physical Summary Scale', 'categories': [{'measurements': [{'value': '2.02', 'spread': '7.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities \\& 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less \\& 5.Limited in kind of work due to physical health, 6.Accomplished less \\& 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm \\& 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted \\& 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '756', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'spread': '47.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300', 'unitOfMeasure': 'Scores on a scale (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25mg once a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '980'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '924'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '852'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}], 'dropWithdraws': [{'type': 'Enrolled, but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Ongoing at Date of Cut-Off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '924', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aromasin (Exemestane)', 'description': 'The recommended dosage of exemestane was 25 mg once a day.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-44 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '450', 'groupId': 'BG000'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '417', 'groupId': 'BG000'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '924', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-23', 'studyFirstSubmitDate': '2010-01-13', 'resultsFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-23', 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores', 'timeFrame': 'Baseline, Month 12', 'description': "10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100"}, {'measure': 'Change From Baseline in Thickness of Endometrium', 'timeFrame': 'Baseline, Month 12', 'description': 'Ultrasound measurement. New derived variable for normalization of endometrium thickness:\n\n1 = Endometrium thickness \\<=5mm 0 = Endometrium thickness \\>5mm'}, {'measure': 'Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26', 'timeFrame': 'Baseline, Month 12', 'description': "Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused - all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100"}, {'measure': 'Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores', 'timeFrame': 'Baseline, Month 12', 'description': 'Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities \\& 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less \\& 5.Limited in kind of work due to physical health, 6.Accomplished less \\& 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm \\& 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted \\& 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.'}, {'measure': 'Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26', 'timeFrame': 'Baseline, Month 12', 'description': 'The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aromatase inhibitor', 'Switch after Tamoxifen', 'Quality of Life', 'Safety'], 'conditions': ['Post Menopausal Women With Early Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991079&StudyName=Sequencing%20Of%20Endocrine%20Therapy%20In%20Post-Menopausal%20Women%20With%20Early%20Breast%20Cancer%20%28FAST%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire.\n\nChange of the endometrium after switching from tamoxifen to Aromasin® (exemestane).\n\nDeeper knowledge of Adverse Events during routine administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.\n\nExclusion Criteria:\n\n* Not applicable.'}, 'identificationModule': {'nctId': 'NCT01050634', 'acronym': 'FAST', 'briefTitle': 'Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin®', 'orgStudyIdInfo': {'id': 'A5991079'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'interventionNames': ['Drug: Aromasin (exemestane)']}], 'interventions': [{'name': 'Aromasin (exemestane)', 'type': 'DRUG', 'otherNames': ['Aromasin, exemestane'], 'description': '25mg oral tablet, daily, for \\>1yr', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}