Viewing Study NCT00066703


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Study NCT ID: NCT00066703
Status: COMPLETED
Last Update Posted: 2025-03-26
First Post: 2003-08-06
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C056516', 'term': 'exemestane'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Heidi.Roschitzki@etop.ibcsg.org', 'phone': '41 31 511 94 00', 'title': 'Dr. Heidi Roschitzki-Voser, PhD Head Trial Activities / Deputy Director', 'organization': 'ETOP IBCSG Partners Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.', 'description': 'Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'T+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.', 'otherNumAtRisk': 1321, 'otherNumAffected': 1293, 'seriousNumAtRisk': 1321, 'seriousNumAffected': 484}, {'id': 'EG001', 'title': 'E+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.', 'otherNumAtRisk': 1317, 'otherNumAffected': 1298, 'seriousNumAtRisk': 1317, 'seriousNumAffected': 496}], 'otherEvents': [{'term': 'Cardiac-ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 446}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 478}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 807}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 760}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection site reaction/extravasation changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 60}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 82}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/embolism (vascular access-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancreatic endocrine: glucose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 388}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 588}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 953}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1030}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, CNS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CNS cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 738}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 714}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 486}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 555}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 592}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 610}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Incontinence, urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 232}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 182}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Vagina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 336}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 374}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 611}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 683}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweating (diaphoresis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 752}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 705}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1081}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1076}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 213}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood/Bone Marrow-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac Arrhythmia-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac-ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Left ventricular diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Cardiac/heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia - Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia - Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia - Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Valvular heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Auditory/Ear-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thyroid function, high (hyperthyroidism, thyrotoxicosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thyroid function, low (hypothyroidism)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Endocrine-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GI - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GI - Varices (rectal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, GI - Small bowel NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Perforation, GI - Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stricture/stenosis (including anastomotic), GI - Esophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ulcer, GI - Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastritis (including bile reflux gastritis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death not associated with CTCAE term - Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection site reaction/extravasation changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Chest/thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, GI - Gallbladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hepatobiliary/Pancreas-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Liver dysfunction/failure (clinical)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Gallbladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergy/Immunology-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Skin (cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Wound complication, non-infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Intra-operative injury - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Intra-operative injury - Vagina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/embolism (vascular access-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vessel injury-vein - Extremity-upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT (serum glutamic oxaloacetic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholesterol, serum-high (hypercholesterolemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Carbon monoxide diffusion capacity (DL(co))', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GGT (gamma-glutamyl transpeptidase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'INR (International Normalized Ratio of prothrombin time)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Triglyceride, serum-high (hypertriglyceridemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancreatic endocrine: glucose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Extremity-upper (function)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Joint-function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphedema-related fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal/Soft Tissue-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 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'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, GU - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary-Other (Specify)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1321, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1317, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GU - Uterus', 'stats': 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orally daily for 5 years. 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Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '93.1'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '94.8'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.777', 'ciLowerLimit': '0.624', 'ciUpperLimit': '0.967', 'estimateComment': 'T+OFS was the reference group in the estimation of the hazard ratio', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5-year estimates reported at a median follow-up of 72 months', 'description': 'Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '1332', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}, {'id': 'OG001', 'title': 'E+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '94.3'}, {'value': '93.4', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '94.4'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.22', 'estimateComment': 'T+OFS was the reference group in the estimation of the hazard ratio', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '8-year estimates, reported at a median follow-up of 9 years', 'description': 'Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}, {'id': 'FG001', 'title': 'E+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1334'}, {'groupId': 'FG001', 'numSubjects': '1338'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '722'}, {'groupId': 'FG001', 'numSubjects': '756'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '612'}, {'groupId': 'FG001', 'numSubjects': '582'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Treatment ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '311'}]}]}], 'recruitmentDetails': '2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'BG000'}, {'value': '1332', 'groupId': 'BG001'}, {'value': '2660', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}, {'id': 'BG001', 'title': 'E+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '46'}, {'value': '43', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '46'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1328', 'groupId': 'BG000'}, {'value': '1332', 'groupId': 'BG001'}, {'value': '2660', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lymph-node status', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.', 'unitOfMeasure': 'percent of participants'}, {'title': 'Tumor size', 'classes': [{'title': '<=2 cm', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': '>=2 cm', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.', 'unitOfMeasure': 'percent of participants'}, {'title': 'Tumor grade', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.', 'unitOfMeasure': 'percent of participants'}, {'title': 'HER2 status', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.', 'unitOfMeasure': 'percent of participants'}], 'populationDescription': 'Intention-to-treat population excludes 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2003-08-06', 'resultsFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2003-08-06', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-07', 'studyFirstPostDateStruct': {'date': '2003-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': '5-year estimate reported at a median follow-up of 72 months', 'description': 'Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.'}], 'secondaryOutcomes': [{'measure': 'Breast Cancer-free Interval', 'timeFrame': '5-year estimate reported at a median follow-up of 72 months', 'description': 'Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.'}, {'measure': 'Distant Recurrence-free Interval', 'timeFrame': '5-year estimates reported at a median follow-up of 72 months', 'description': 'Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up'}, {'measure': 'Overall Survival', 'timeFrame': '8-year estimates, reported at a median follow-up of 9 years', 'description': 'Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'estrogen receptor-positive breast cancer', 'progesterone receptor-positive breast cancer', 'stage IA breast cancer', 'stage IB breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.'}, {'pmid': '18325918', 'type': 'BACKGROUND', 'citation': 'Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thurlimann B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD; SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group. Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol. 2008 Jul;19(7):1231-1241. doi: 10.1093/annonc/mdn037. Epub 2008 Mar 5.'}, {'pmid': '20482225', 'type': 'BACKGROUND', 'citation': 'Rabaglio M, Ruepp B; Soft/Text/Perche Steering Committee. Death due to liver failure during endocrine therapy for premenopausal breast cancer. Acta Oncol. 2010 Aug;49(6):874-6. doi: 10.3109/0284186X.2010.484813. No abstract available.'}, {'pmid': '24095609', 'type': 'BACKGROUND', 'citation': 'Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA; International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2.'}, {'pmid': '24881463', 'type': 'RESULT', 'citation': 'Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.'}, {'pmid': '36521078', 'type': 'RESULT', 'citation': 'Pagani O, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan MM, Francis PA; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 1;41(7):1376-1382. doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15.'}, {'pmid': '40986647', 'type': 'DERIVED', 'citation': 'Ribi K, Cole BF, Fleming GF, Walley BA, Francis PA, Abdi E, Burstein HJ, Cheng KL, Chia SKL, Dakhil SR, Davidson NE, Della-Fiorentina SA, Frith AE, Levine E, Lupichuk S, Pritchard K, Salim M, Stearns V, Stewart J, Valero V, van der Westhuizen A, Pagani O, Loi S, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Prognostic value of patient-reported depression in women with hormone-responsive early breast cancer in TEXT and SOFT. Cancer. 2025 Oct 1;131(19):e70094. doi: 10.1002/cncr.70094.'}, {'pmid': '31618131', 'type': 'DERIVED', 'citation': 'Pagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM; SOFT and TEXT Investigators and International Breast Cancer Study Group. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16.'}, {'pmid': '29863451', 'type': 'DERIVED', 'citation': 'Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4.'}, {'pmid': '28911092', 'type': 'DERIVED', 'citation': 'Regan MM, Walley BA, Francis PA, Fleming GF, Lang I, Gomez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol. 2017 Sep 1;28(9):2225-2232. doi: 10.1093/annonc/mdx285.'}, {'pmid': '27825388', 'type': 'DERIVED', 'citation': 'Johansson H, Gray KP, Pagani O, Regan MM, Viale G, Aristarco V, Macis D, Puccio A, Roux S, Maibach R, Colleoni M, Rabaglio M, Price KN, Coates AS, Gelber RD, Goldhirsch A, Kammler R, Bonanni B, Walley BA; the TEXT principal investigators. Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 Nov 8;18(1):110. doi: 10.1186/s13058-016-0771-8.'}, {'pmid': '27044936', 'type': 'DERIVED', 'citation': 'Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4.'}, {'pmid': '26092816', 'type': 'DERIVED', 'citation': 'Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015 Jul;16(7):848-58. doi: 10.1016/S1470-2045(15)00049-2. Epub 2015 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.\n\nPURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.\n* Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.\n\nOUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n* Completely resected disease\n\n * No clinically detectable residual loco-regional axillary disease\n * Prior surgery for primary breast cancer of 1 of the following types:\n\n * Total mastectomy with or without adjuvant radiotherapy\n * Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative\\* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: \\*If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed\n* Tumor confined to the breast and axillary nodes\n\n * Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed\n* Axillary lymph node dissection or a negative axillary sentinel node biopsy required\n\n * Patients with negative or microscopically positive axillary sentinel nodes are eligible\n * Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes\n* No distant metastases\n* No locally advanced inoperable breast cancer, including any of the following:\n\n * Inflammatory breast cancer\n * Supraclavicular node involvement\n * Enlarged internal mammary nodes (unless pathologically negative)\n* Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria\n* No prior ipsilateral or contralateral invasive breast cancer\n* Hormone receptor status:\n\n * Estrogen and/or progesterone receptor positive\n\n * At least 10% of the tumor cells positive by immunohistochemistry\n * If \\> 1 breast tumor, each tumor must be hormone receptor positive\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Premenopausal\n\nSex\n\n* Female\n\nMenopausal status\n\n* Premenopausal\n\n * Estradiol in the premenopausal range after prior surgery OR meets the following criteria:\n\n * Menstruating regularly for the past 6 months\n * Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* No systemic hepatic disease that would preclude prolonged follow-up\n\nRenal\n\n* No systemic renal disease that would preclude prolonged follow-up\n\nCardiovascular\n\n* No systemic cardiovascular disease that would preclude prolonged follow-up\n* No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable\n\nPulmonary\n\n* No systemic pulmonary disease that would preclude prolonged follow-up\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective nonhormonal contraception\n* No history of noncompliance to medical regimens\n* No other nonmalignant systemic disease that would preclude prolonged follow-up\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:\n\n * Stage I papillary thyroid cancer\n * Stage IA carcinoma of the cervix\n * Stage IA or B endometrioid endometrial cancer\n * Borderline or stage I ovarian cancer\n* No psychiatric, addictive, or other disorder that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed\n\nChemotherapy\n\n* No prior neoadjuvant or adjuvant chemotherapy\n\nEndocrine therapy\n\n* No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis\n* No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer\n* No concurrent oral or transdermal hormonal therapy\n* No other concurrent estrogen, progesterone, or androgens\n* No other concurrent aromatase inhibitors\n* No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior ovarian radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* No prior bilateral oophorectomy\n\nOther\n\n* No concurrent bisphosphonates, except in the following cases:\n\n * Bone density is at least 1.5 standard deviations below the young adult normal mean\n * Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00066703', 'acronym': 'TEXT', 'briefTitle': 'Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'ETOP IBCSG Partners Foundation'}, 'officialTitle': 'A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer', 'orgStudyIdInfo': {'id': 'IBCSG 25-02 / BIG 3-02'}, 'secondaryIdInfos': [{'id': 'IBCSG 25-02'}, {'id': 'BIG 3-02', 'type': 'OTHER', 'domain': 'Breast International Group'}, {'id': 'NABCI IBCSG 25-02'}, {'id': 'EU-20347'}, {'id': '2004-000168-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'CDR0000316458', 'type': 'REGISTRY', 'domain': 'CT.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.', 'interventionNames': ['Drug: tamoxifen', 'Drug: triptorelin']}, {'type': 'EXPERIMENTAL', 'label': 'E+OFS', 'description': 'Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.', 'interventionNames': ['Drug: exemestane', 'Drug: triptorelin']}], 'interventions': [{'name': 'exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin'], 'armGroupLabels': ['E+OFS']}, {'name': 'tamoxifen', 'type': 'DRUG', 'otherNames': ['Nolvadex'], 'armGroupLabels': ['T+OFS']}, {'name': 'triptorelin', 'type': 'DRUG', 'otherNames': ['GnRH analogue', 'Trelstar Depot', 'Decapeptyl Depot'], 'armGroupLabels': ['E+OFS', 'T+OFS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91346-9600', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Providence Holy Cross Cancer Center', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Regional Medical Center Comprehensive Cancer Center', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center at Roseville Medical Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy General Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Ruby L. 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