Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 9:34 AM
Study NCT ID:
NCT00038467
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2002-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Montenegro', 'Serbia and Montenegro']}, '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': 'D013629', 'term': 'Tamoxifen'}, {'id': 'C056516', 'term': 'exemestane'}], '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'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Other AEs included both SAEs and AEs. Non-SAE could not be presented separately for this study as AEs were collected in clinical database where SAE flags were not collected.'}}, 'adverseEventsModule': {'description': 'SAEs, AEs collected in separate databases.For SAE:treated population included all randomized participants with at least 1 study drug administration as per actual treatment received.For AE:safety population included all participants in treated population with at least 1 on-treatment AE assessment.AEs included AEs and illnesses reported during study.', 'eventGroups': [{'id': 'EG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.', 'otherNumAtRisk': 2249, 'otherNumAffected': 1905, 'seriousNumAtRisk': 2320, 'seriousNumAffected': 383}, {'id': 'EG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.', 'otherNumAtRisk': 2279, 'otherNumAffected': 1888, 'seriousNumAtRisk': 2338, 'seriousNumAffected': 439}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 208}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 367}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 344}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 138}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 396}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 246}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 176}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Osteoarthritis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 106}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Osteoporosis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 66}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Pain in limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 108}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 224}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 200}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 305}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 255}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 127}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 290}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 205}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 121}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Sweating increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 242}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Hot flushes NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 491}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 457}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}, {'term': 'Hypertension NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2249, 'numAffected': 223}, {'groupId': 'EG001', 'numAtRisk': 2279, 'numAffected': 191}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypofibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Porphyria non-acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Auricular perichondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endocrine disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Strabismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal strangulated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diverticulitis oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 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'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Enthesopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 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{'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 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'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cervix carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cervix carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contralateral breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Inflammatory carcinoma of the breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sarcoma uterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Schwannoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Second primary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebrovascular accident', 'stats': 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'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast lump removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast prosthesis removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast reconstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dacryocystorhinostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laparotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Maxillofacial operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meniscus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal septal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Plastic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Scar excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vaginoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Varicose vein operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2352', 'groupId': 'OG000'}, {'value': '2372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '0.92'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '0.88'}]}]}], 'analyses': [{'pValue': '0.00003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.82', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 36', 'description': 'DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.', 'unitOfMeasure': 'probability of DFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) at Month 36 Post-Randomization: Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2352', 'groupId': 'OG000'}, {'value': '2372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.953', 'groupId': 'OG000', 'lowerLimit': '0.945', 'upperLimit': '0.962'}, {'value': '0.941', 'groupId': 'OG001', 'lowerLimit': '0.932', 'upperLimit': '0.951'}]}]}], 'analyses': [{'pValue': '0.15737', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.913', 'ciLowerLimit': '0.806', 'ciUpperLimit': '1.036', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 120', 'description': "OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.", 'unitOfMeasure': 'probability of OS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Events of Second Breast Cancer in Contralateral Breast: Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2352', 'groupId': 'OG000'}, {'value': '2372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 120', 'description': 'Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 6 months on-treatment: LS (n=84,96)', 'categories': [{'measurements': [{'value': '-2.64', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months on-treatment: TH (n=82,96)', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: LS (n=82,96)', 'categories': [{'measurements': [{'value': '-2.98', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: TH (n=82,95)', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: LS (n=82,92)', 'categories': [{'measurements': [{'value': '-3.69', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: TH (n=79,93)', 'categories': [{'measurements': [{'value': '-2.81', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: LS (n=74,81)', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: TH (n=73,84)', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '-4.15', 'spread': '4.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.63', 'ciUpperLimit': '3.23', 'groupDescription': '6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.79', 'groupDescription': '6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.79', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.81', 'groupDescription': '12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.12', 'ciUpperLimit': '2.46', 'groupDescription': '12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.22', 'ciLowerLimit': '2.10', 'ciUpperLimit': '4.35', 'groupDescription': '24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.69', 'groupDescription': '24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \\[TH\\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 6 months on-treatment: FN (n=82,94)', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months on-treatment: FW (n=82,94)', 'categories': [{'measurements': [{'value': '-2.02', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '5.53', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: FN (n=82,95)', 'categories': [{'measurements': [{'value': '-2.56', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '3.60', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: FW (n=81,95)', 'categories': [{'measurements': [{'value': '-3.51', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '5.84', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: FN (n=78,89)', 'categories': [{'measurements': [{'value': '-4.00', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '4.85', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: FW (n=72,87)', 'categories': [{'measurements': [{'value': '-4.75', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: FN (n=61,69)', 'categories': [{'measurements': [{'value': '-4.10', 'spread': '5.57', 'groupId': 'OG000'}, {'value': '-4.95', 'spread': '6.46', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: FW (n=60,68)', 'categories': [{'measurements': [{'value': '-6.07', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '-8.60', 'spread': '8.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Baseline: LS (n=86,99)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: TH (n=86,99)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months on-treatment: LS (n=84,96)', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months on-treatment: TH (n=82,96)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: LS (n=82,96)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months on-treatment: TH (n=82,95)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: LS (n=82,92)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months on-treatment: TH (n=79,93)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: LS (n=74,81)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months post-treatment: TH (n=73,84)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \\[TH\\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (\\>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (\\<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '3 months: on-treatment (n=81, 92)', 'categories': [{'measurements': [{'value': '113.47', 'groupId': 'OG000', 'lowerLimit': '108.74', 'upperLimit': '118.41'}, {'value': '104.35', 'groupId': 'OG001', 'lowerLimit': '100.03', 'upperLimit': '108.85'}]}]}, {'title': '6 months: on-treatment (n=83, 95)', 'categories': [{'measurements': [{'value': '121.01', 'groupId': 'OG000', 'lowerLimit': '107.99', 'upperLimit': '135.60'}, {'value': '104.34', 'groupId': 'OG001', 'lowerLimit': '99.18', 'upperLimit': '109.76'}]}]}, {'title': '9 months: on-treatment (n=79, 92)', 'categories': [{'measurements': [{'value': '139.62', 'groupId': 'OG000', 'lowerLimit': '131.65', 'upperLimit': '148.06'}, {'value': '98.17', 'groupId': 'OG001', 'lowerLimit': '92.95', 'upperLimit': '103.67'}]}]}, {'title': '12 months: on-treatment (n=82, 96)', 'categories': [{'measurements': [{'value': '148.96', 'groupId': 'OG000', 'lowerLimit': '139.83', 'upperLimit': '158.68'}, {'value': '100.47', 'groupId': 'OG001', 'lowerLimit': '94.36', 'upperLimit': '106.97'}]}]}, {'title': '18 months: on-treatment (n=80, 95)', 'categories': [{'measurements': [{'value': '158.33', 'groupId': 'OG000', 'lowerLimit': '147.97', 'upperLimit': '169.41'}, {'value': '102.72', 'groupId': 'OG001', 'lowerLimit': '96.18', 'upperLimit': '109.69'}]}]}, {'title': '24 months: on-treatment (n=81, 90)', 'categories': [{'measurements': [{'value': '155.89', 'groupId': 'OG000', 'lowerLimit': '145.04', 'upperLimit': '167.56'}, {'value': '105.12', 'groupId': 'OG001', 'lowerLimit': '98.36', 'upperLimit': '112.35'}]}]}, {'title': '30 months: on-treatment (n=50, 65)', 'categories': [{'measurements': [{'value': '144.89', 'groupId': 'OG000', 'lowerLimit': '125.83', 'upperLimit': '166.83'}, {'value': '108.33', 'groupId': 'OG001', 'lowerLimit': '99.51', 'upperLimit': '117.94'}]}]}, {'title': '36 months: end of treatment (n=19, 31)', 'categories': [{'measurements': [{'value': '150.82', 'groupId': 'OG000', 'lowerLimit': '127.82', 'upperLimit': '177.97'}, {'value': '113.87', 'groupId': 'OG001', 'lowerLimit': '101.28', 'upperLimit': '128.03'}]}]}, {'title': '12 months: post-treatment (n=67, 87)', 'categories': [{'measurements': [{'value': '140.19', 'groupId': 'OG000', 'lowerLimit': '129.98', 'upperLimit': '151.19'}, {'value': '149.69', 'groupId': 'OG001', 'lowerLimit': '138.34', 'upperLimit': '161.97'}]}]}, {'title': '24 months: post-treatment (n=62, 77)', 'categories': [{'measurements': [{'value': '128.73', 'groupId': 'OG000', 'lowerLimit': '114.70', 'upperLimit': '144.48'}, {'value': '142.20', 'groupId': 'OG001', 'lowerLimit': '129.09', 'upperLimit': '156.64'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.'}, {'type': 'SECONDARY', 'title': 'Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '3 months: on-treatment (n=81, 93)', 'categories': [{'measurements': [{'value': '144.14', 'groupId': 'OG000', 'lowerLimit': '127.25', 'upperLimit': '163.27'}, {'value': '99.19', 'groupId': 'OG001', 'lowerLimit': '89.37', 'upperLimit': '110.09'}]}]}, {'title': '6 months: on-treatment (n=83, 95)', 'categories': [{'measurements': [{'value': '197.47', 'groupId': 'OG000', 'lowerLimit': '176.51', 'upperLimit': '220.92'}, {'value': '93.67', 'groupId': 'OG001', 'lowerLimit': '84.75', 'upperLimit': '103.51'}]}]}, {'title': '9 months: on-treatment (n=79, 92)', 'categories': [{'measurements': [{'value': '226.04', 'groupId': 'OG000', 'lowerLimit': '202.51', 'upperLimit': '252.30'}, {'value': '94.40', 'groupId': 'OG001', 'lowerLimit': '85.44', 'upperLimit': '104.29'}]}]}, {'title': '12 months: on-treatment (n=81, 96)', 'categories': [{'measurements': [{'value': '232.69', 'groupId': 'OG000', 'lowerLimit': '206.42', 'upperLimit': '262.31'}, {'value': '94.59', 'groupId': 'OG001', 'lowerLimit': '86.27', 'upperLimit': '103.71'}]}]}, {'title': '18 months: on-treatment (n=80, 95)', 'categories': [{'measurements': [{'value': '199.68', 'groupId': 'OG000', 'lowerLimit': '171.75', 'upperLimit': '232.15'}, {'value': '90.35', 'groupId': 'OG001', 'lowerLimit': '81.82', 'upperLimit': '99.76'}]}]}, {'title': '24 months: on-treatment (n=81, 90)', 'categories': [{'measurements': [{'value': '177.80', 'groupId': 'OG000', 'lowerLimit': '154.58', 'upperLimit': '204.50'}, {'value': '88.80', 'groupId': 'OG001', 'lowerLimit': '78.96', 'upperLimit': '99.87'}]}]}, {'title': '30 months: on-treatment (n=50, 65)', 'categories': [{'measurements': [{'value': '179.29', 'groupId': 'OG000', 'lowerLimit': '150.83', 'upperLimit': '213.11'}, {'value': '91.62', 'groupId': 'OG001', 'lowerLimit': '80.20', 'upperLimit': '104.66'}]}]}, {'title': '36 months: end of treatment (n=19, 31)', 'categories': [{'measurements': [{'value': '130.00', 'groupId': 'OG000', 'lowerLimit': '94.91', 'upperLimit': '178.06'}, {'value': '99.34', 'groupId': 'OG001', 'lowerLimit': '81.16', 'upperLimit': '121.58'}]}]}, {'title': '12 months: post-treatment (n=67, 87)', 'categories': [{'measurements': [{'value': '110.87', 'groupId': 'OG000', 'lowerLimit': '94.93', 'upperLimit': '129.49'}, {'value': '136.50', 'groupId': 'OG001', 'lowerLimit': '121.05', 'upperLimit': '153.91'}]}]}, {'title': '24 months: post-treatment (n=62, 77)', 'categories': [{'measurements': [{'value': '100.34', 'groupId': 'OG000', 'lowerLimit': '84.62', 'upperLimit': '118.98'}, {'value': '124.03', 'groupId': 'OG001', 'lowerLimit': '109.98', 'upperLimit': '139.88'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '3 months, on-treatment: OC (n=81, 92)', 'categories': [{'measurements': [{'value': '149.49', 'groupId': 'OG000', 'lowerLimit': '137.88', 'upperLimit': '162.09'}, {'value': '101.02', 'groupId': 'OG001', 'lowerLimit': '94.14', 'upperLimit': '108.40'}]}]}, {'title': '3 months, on-treatment: PICP (n=81, 92)', 'categories': [{'measurements': [{'value': '117.23', 'groupId': 'OG000', 'lowerLimit': '109.63', 'upperLimit': '125.35'}, {'value': '102.19', 'groupId': 'OG001', 'lowerLimit': '97.34', 'upperLimit': '107.27'}]}]}, {'title': '6 months, on-treatment: OC (n=83, 95)', 'categories': [{'measurements': [{'value': '193.44', 'groupId': 'OG000', 'lowerLimit': '177.49', 'upperLimit': '210.81'}, {'value': '97.69', 'groupId': 'OG001', 'lowerLimit': '91.78', 'upperLimit': '103.98'}]}]}, {'title': '6 months, on-treatment: PICP (n=83, 95)', 'categories': [{'measurements': [{'value': '133.50', 'groupId': 'OG000', 'lowerLimit': '125.30', 'upperLimit': '142.23'}, {'value': '99.78', 'groupId': 'OG001', 'lowerLimit': '95.18', 'upperLimit': '104.61'}]}]}, {'title': '9 months, on-treatment: OC (n=79, 93)', 'categories': [{'measurements': [{'value': '230.41', 'groupId': 'OG000', 'lowerLimit': '209.80', 'upperLimit': '253.05'}, {'value': '92.52', 'groupId': 'OG001', 'lowerLimit': '86.02', 'upperLimit': '99.50'}]}]}, {'title': '9 months, on-treatment: PICP (n=79, 92)', 'categories': [{'measurements': [{'value': '131.73', 'groupId': 'OG000', 'lowerLimit': '124.27', 'upperLimit': '139.63'}, {'value': '96.52', 'groupId': 'OG001', 'lowerLimit': '91.21', 'upperLimit': '102.14'}]}]}, {'title': '12 months, on-treatment: OC (n=82, 96)', 'categories': [{'measurements': [{'value': '227.59', 'groupId': 'OG000', 'lowerLimit': '208.40', 'upperLimit': '248.56'}, {'value': '95.75', 'groupId': 'OG001', 'lowerLimit': '88.46', 'upperLimit': '103.65'}]}]}, {'title': '12 months, on-treatment: PICP (n=82, 96)', 'categories': [{'measurements': [{'value': '128.68', 'groupId': 'OG000', 'lowerLimit': '122.22', 'upperLimit': '135.50'}, {'value': '100.18', 'groupId': 'OG001', 'lowerLimit': '95.23', 'upperLimit': '105.39'}]}]}, {'title': '18 months, on-treatment: OC (n=80, 95)', 'categories': [{'measurements': [{'value': '230.72', 'groupId': 'OG000', 'lowerLimit': '207.16', 'upperLimit': '256.95'}, {'value': '93.98', 'groupId': 'OG001', 'lowerLimit': '87.54', 'upperLimit': '100.90'}]}]}, {'title': '18 months, on-treatment: PICP (n=80, 95)', 'categories': [{'measurements': [{'value': '125.40', 'groupId': 'OG000', 'lowerLimit': '116.86', 'upperLimit': '134.56'}, {'value': '103.25', 'groupId': 'OG001', 'lowerLimit': '97.38', 'upperLimit': '109.47'}]}]}, {'title': '24 months, on-treatment: OC (n=81, 90)', 'categories': [{'measurements': [{'value': '190.18', 'groupId': 'OG000', 'lowerLimit': '171.07', 'upperLimit': '211.41'}, {'value': '89.29', 'groupId': 'OG001', 'lowerLimit': '82.19', 'upperLimit': '97.00'}]}]}, {'title': '24 months: on-treatment: PICP (n=81, 90)', 'categories': [{'measurements': [{'value': '123.75', 'groupId': 'OG000', 'lowerLimit': '115.11', 'upperLimit': '133.05'}, {'value': '103.94', 'groupId': 'OG001', 'lowerLimit': '97.75', 'upperLimit': '110.52'}]}]}, {'title': '30 months, on-treatment: OC (n=50, 65)', 'categories': [{'measurements': [{'value': '187.23', 'groupId': 'OG000', 'lowerLimit': '165.02', 'upperLimit': '212.43'}, {'value': '87.34', 'groupId': 'OG001', 'lowerLimit': '79.64', 'upperLimit': '95.79'}]}]}, {'title': '30 months, on-treatment: PICP (n=50, 65)', 'categories': [{'measurements': [{'value': '113.76', 'groupId': 'OG000', 'lowerLimit': '102.05', 'upperLimit': '126.82'}, {'value': '103.36', 'groupId': 'OG001', 'lowerLimit': '94.57', 'upperLimit': '112.97'}]}]}, {'title': '36 months, end of treatment: OC (n=19, 30)', 'categories': [{'measurements': [{'value': '167.03', 'groupId': 'OG000', 'lowerLimit': '121.37', 'upperLimit': '229.86'}, {'value': '90.77', 'groupId': 'OG001', 'lowerLimit': '76.63', 'upperLimit': '107.52'}]}]}, {'title': '36 months, end of treatment: PICP (n=19, 31)', 'categories': [{'measurements': [{'value': '95.33', 'groupId': 'OG000', 'lowerLimit': '79.82', 'upperLimit': '113.84'}, {'value': '87.22', 'groupId': 'OG001', 'lowerLimit': '76.34', 'upperLimit': '99.66'}]}]}, {'title': '12 months, post-treatment: OC (n=67, 87)', 'categories': [{'measurements': [{'value': '143.85', 'groupId': 'OG000', 'lowerLimit': '125.83', 'upperLimit': '164.44'}, {'value': '152.32', 'groupId': 'OG001', 'lowerLimit': '135.49', 'upperLimit': '171.24'}]}]}, {'title': '12 months, post-treatment: PICP (n=67, 87)', 'categories': [{'measurements': [{'value': '91.53', 'groupId': 'OG000', 'lowerLimit': '84.27', 'upperLimit': '99.42'}, {'value': '108.67', 'groupId': 'OG001', 'lowerLimit': '100.59', 'upperLimit': '117.39'}]}]}, {'title': '24 months, post-treatment: OC (n=62, 77)', 'categories': [{'measurements': [{'value': '130.78', 'groupId': 'OG000', 'lowerLimit': '114.03', 'upperLimit': '150.00'}, {'value': '146.36', 'groupId': 'OG001', 'lowerLimit': '128.87', 'upperLimit': '166.22'}]}]}, {'title': '24 months, post-treatment: PICP (n=62, 77)', 'categories': [{'measurements': [{'value': '90.46', 'groupId': 'OG000', 'lowerLimit': '81.68', 'upperLimit': '100.19'}, {'value': '100.74', 'groupId': 'OG001', 'lowerLimit': '92.95', 'upperLimit': '109.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.", 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '3 months: on-treatment (n=82, 91)', 'categories': [{'measurements': [{'value': '130.49', 'groupId': 'OG000', 'lowerLimit': '121.56', 'upperLimit': '140.07'}, {'value': '106.99', 'groupId': 'OG001', 'lowerLimit': '99.66', 'upperLimit': '114.85'}]}]}, {'title': '6 months: on-treatment (n=83, 95)', 'categories': [{'measurements': [{'value': '145.13', 'groupId': 'OG000', 'lowerLimit': '133.61', 'upperLimit': '157.64'}, {'value': '103.42', 'groupId': 'OG001', 'lowerLimit': '96.64', 'upperLimit': '110.68'}]}]}, {'title': '9 months: on-treatment (n=80, 92)', 'categories': [{'measurements': [{'value': '160.12', 'groupId': 'OG000', 'lowerLimit': '147.40', 'upperLimit': '173.93'}, {'value': '101.08', 'groupId': 'OG001', 'lowerLimit': '94.85', 'upperLimit': '107.72'}]}]}, {'title': '12 months: on-treatment (n=82, 97)', 'categories': [{'measurements': [{'value': '155.53', 'groupId': 'OG000', 'lowerLimit': '143.40', 'upperLimit': '168.70'}, {'value': '104.51', 'groupId': 'OG001', 'lowerLimit': '98.23', 'upperLimit': '111.19'}]}]}, {'title': '18 months: on-treatment (n=77, 96)', 'categories': [{'measurements': [{'value': '139.57', 'groupId': 'OG000', 'lowerLimit': '129.65', 'upperLimit': '150.25'}, {'value': '99.25', 'groupId': 'OG001', 'lowerLimit': '93.11', 'upperLimit': '105.78'}]}]}, {'title': '24 months: on-treatment (n=78, 90)', 'categories': [{'measurements': [{'value': '135.30', 'groupId': 'OG000', 'lowerLimit': '125.10', 'upperLimit': '146.33'}, {'value': '99.11', 'groupId': 'OG001', 'lowerLimit': '92.56', 'upperLimit': '106.12'}]}]}, {'title': '30 months: on-treatment (n=49, 63)', 'categories': [{'measurements': [{'value': '121.39', 'groupId': 'OG000', 'lowerLimit': '108.66', 'upperLimit': '135.62'}, {'value': '95.97', 'groupId': 'OG001', 'lowerLimit': '87.65', 'upperLimit': '105.07'}]}]}, {'title': '36 months: end of treatment (n=19, 31)', 'categories': [{'measurements': [{'value': '107.64', 'groupId': 'OG000', 'lowerLimit': '89.11', 'upperLimit': '130.02'}, {'value': '101.04', 'groupId': 'OG001', 'lowerLimit': '86.77', 'upperLimit': '117.65'}]}]}, {'title': '12 months: post-treatment (n=65, 84)', 'categories': [{'measurements': [{'value': '117.94', 'groupId': 'OG000', 'lowerLimit': '107.07', 'upperLimit': '129.92'}, {'value': '128.47', 'groupId': 'OG001', 'lowerLimit': '118.34', 'upperLimit': '139.46'}]}]}, {'title': '24 months: post-treatment (n=61, 77)', 'categories': [{'measurements': [{'value': '105.50', 'groupId': 'OG000', 'lowerLimit': '96.08', 'upperLimit': '115.84'}, {'value': '120.84', 'groupId': 'OG001', 'lowerLimit': '112.37', 'upperLimit': '129.96'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.'}, {'type': 'SECONDARY', 'title': 'Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '3 months: on-treatment (n=82, 91)', 'categories': [{'measurements': [{'value': '128.35', 'groupId': 'OG000', 'lowerLimit': '118.11', 'upperLimit': '139.48'}, {'value': '101.92', 'groupId': 'OG001', 'lowerLimit': '94.39', 'upperLimit': '110.05'}]}]}, {'title': '6 months: on-treatment (n=83, 95)', 'categories': [{'measurements': [{'value': '153.67', 'groupId': 'OG000', 'lowerLimit': '141.89', 'upperLimit': '166.44'}, {'value': '100.64', 'groupId': 'OG001', 'lowerLimit': '92.92', 'upperLimit': '109.00'}]}]}, {'title': '9 months: on-treatment (n=80, 92)', 'categories': [{'measurements': [{'value': '168.15', 'groupId': 'OG000', 'lowerLimit': '152.93', 'upperLimit': '184.90'}, {'value': '101.44', 'groupId': 'OG001', 'lowerLimit': '92.13', 'upperLimit': '111.68'}]}]}, {'title': '12 months: on-treatment (n=82, 97)', 'categories': [{'measurements': [{'value': '177.58', 'groupId': 'OG000', 'lowerLimit': '160.20', 'upperLimit': '196.85'}, {'value': '104.42', 'groupId': 'OG001', 'lowerLimit': '96.57', 'upperLimit': '112.91'}]}]}, {'title': '18 months: on-treatment (n=77, 96)', 'categories': [{'measurements': [{'value': '171.46', 'groupId': 'OG000', 'lowerLimit': '153.32', 'upperLimit': '191.75'}, {'value': '98.74', 'groupId': 'OG001', 'lowerLimit': '89.88', 'upperLimit': '108.46'}]}]}, {'title': '24 months: on-treatment (n=78, 90)', 'categories': [{'measurements': [{'value': '167.87', 'groupId': 'OG000', 'lowerLimit': '148.36', 'upperLimit': '189.95'}, {'value': '104.55', 'groupId': 'OG001', 'lowerLimit': '93.40', 'upperLimit': '117.03'}]}]}, {'title': '30 months: on-treatment (n=49, 63)', 'categories': [{'measurements': [{'value': '168.52', 'groupId': 'OG000', 'lowerLimit': '144.54', 'upperLimit': '196.48'}, {'value': '96.51', 'groupId': 'OG001', 'lowerLimit': '83.74', 'upperLimit': '111.22'}]}]}, {'title': '36 months: end of treatment (n=19, 31)', 'categories': [{'measurements': [{'value': '152.13', 'groupId': 'OG000', 'lowerLimit': '112.43', 'upperLimit': '205.87'}, {'value': '105.58', 'groupId': 'OG001', 'lowerLimit': '84.56', 'upperLimit': '131.83'}]}]}, {'title': '12 months: post-treatment (n=65, 84)', 'categories': [{'measurements': [{'value': '121.00', 'groupId': 'OG000', 'lowerLimit': '101.05', 'upperLimit': '144.88'}, {'value': '158.12', 'groupId': 'OG001', 'lowerLimit': '139.47', 'upperLimit': '179.26'}]}]}, {'title': '24 months: post-treatment (n=61, 77)', 'categories': [{'measurements': [{'value': '108.18', 'groupId': 'OG000', 'lowerLimit': '108.18', 'upperLimit': '129.77'}, {'value': '143.98', 'groupId': 'OG001', 'lowerLimit': '124.26', 'upperLimit': '166.83'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Fracture: Bone Metabolism Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post-treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=251, 251)', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '7.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=244, 243)', 'categories': [{'measurements': [{'value': '-2.10', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=242, 235)', 'categories': [{'measurements': [{'value': '-1.18', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '8.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=230, 238)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '8.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=232, 227)', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=221, 213)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '8.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.500', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '0.86', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-3.67', 'ciUpperLimit': '-0.52', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-2.86', 'ciUpperLimit': '0.16', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '1.77', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-2.43', 'ciUpperLimit': '0.75', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-2.76', 'ciUpperLimit': '0.54', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version \\[FACT-B\\] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=254, 253)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '6.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=245, 243)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '6.54', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 238)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '6.29', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=233, 236)', 'categories': [{'measurements': [{'value': '1.98', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '7.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=235, 226)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=222, 214)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '6.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '0.49', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '0.44', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.698', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '0.92', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '2.09', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '1.15', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '1.75', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=252, 252)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '16.17', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=244, 243)', 'categories': [{'measurements': [{'value': '-3.12', 'spread': '17.84', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '16.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 236)', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '15.09', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '17.99', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=229, 236)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '18.91', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '14.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=232, 225)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '17.37', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=220, 212)', 'categories': [{'measurements': [{'value': '-1.48', 'spread': '22.44', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '16.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-3.46', 'ciUpperLimit': '2.42', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.08', 'ciLowerLimit': '-6.12', 'ciUpperLimit': '-0.05', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '2.08', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '3.99', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-3.83', 'ciUpperLimit': '2.36', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.91', 'ciLowerLimit': '-6.63', 'ciUpperLimit': '0.82', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=253, 252)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months(n=246, 244)', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '2.88', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=242, 237)', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=233, 238)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '3.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months(n=234, 228)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=223, 214)', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.208', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.214', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.265', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.23', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '-0.57', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.13', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.635', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.43', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.33', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.454', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.36', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=252, 249)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '3.59', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=245, 241)', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=242, 235)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=231, 235)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '3.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months(n=234, 226)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=219, 212)', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '4.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.712', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.335', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.899', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.356', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.882', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.359', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.37', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.454', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=254, 250)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=244, 240)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 235)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=233, 233)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=233, 222)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=221, 213)', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.18', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.24', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.21', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.27', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.41', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.34', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=255, 252)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '2.77', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=246, 243)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 236)', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=232, 235)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=235, 226)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=222, 214)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '3.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.792', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.56', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.31', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.36', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.80', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.381', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.32', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.33', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=254, 253)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=246, 244)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 238)', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '3.62', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=232, 238)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=232, 227)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=222, 214)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.48', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.366', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.40', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '0.03', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.545', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '1.00', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.70', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.244', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '0.32', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Change at 3 months (n=255, 252)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months (n=246, 244)', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at 9 months (n=243, 239)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months (n=233, 238)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months (n=233, 227)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '4.61', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '4.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 months (n=222, 214)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '4.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.73', 'groupDescription': '3 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.26', 'groupDescription': '6 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.630', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.55', 'groupDescription': '9 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.530', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.98', 'groupDescription': '12 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '0.21', 'groupDescription': '18 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.46', 'groupDescription': '24 months: p-value was estimated using 2-sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe Endocrine Symptoms: QoL Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Hot flushes', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Cold sweats', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Night sweats', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Sleeping difficulties', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Lack of energy', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Nervous feeling', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Lightheaded/dizzy', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Headaches', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Mood swings', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Feeling irritable', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Gained weight', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Bloated feeling', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal discharge', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal irritation', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal bleeding', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal dryness', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Discomfort with intercourse', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Lost interest in sex', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Breast tenderness', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Feeling ill', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Side effects', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months after randomization', 'description': 'Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': '6 months (n=58, 49)', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}]}]}, {'title': '12 months (n=60, 52)', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}]}]}, {'title': '24 months (n=61, 52)', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '63.5', 'groupId': 'OG001'}]}]}, {'title': '36 months (n=32, 17)', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': '6 months post-treatment (n=16, 17)', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}]}]}, {'title': '12 months post-treatment (n=50, 37)', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}, {'title': '24 months post-treatment (n=41, 31)', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0174', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '6 months: p-value for percentage of participants with an endometrial thickness of \\>=5 mm was analyzed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '12 months: p-value for percentage of participants with an endometrial thickness of \\>=5 mm was analyzed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '24 months: p-value for percentage of participants with an endometrial thickness of \\>=5 mm was analyzed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8084', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \\>=5 mm was analyzed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6449', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \\>=5 mm was analyzed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Endometrial Thickness: Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'Baseline (n=60, 52)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '29.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '29.0'}]}]}, {'title': '6 months (n=58, 49)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '16.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '23.0'}]}]}, {'title': '12 months (n=59, 52)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '20.4'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '39.0'}]}]}, {'title': '24 months (n=60, 52)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '19.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '26.0'}]}]}, {'title': '36 months (n=31, 17)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '12.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24.0'}]}]}, {'title': '6 months post-treatment (n=16, 17)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '16.6'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '17.0'}]}]}, {'title': '12 months post-treatment (n=49, 37)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '17.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '16.0'}]}]}, {'title': '24 months post-treatment (n=40, 31)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '21.0'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Uterine and Overall Ovary Volume: Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'UV: 6 months (n=57, 47)', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '180.0'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '149.8'}]}]}, {'title': 'OV: 6 months (n=8, 6)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '9.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.2'}]}]}, {'title': 'UV: 12 months (n=56, 49)', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '58.3'}, {'value': '39.2', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '214.2'}]}]}, {'title': 'OV: 12 months (n=6, 5)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '3.8'}]}]}, {'title': 'UV: 24 months (n=54, 51)', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '73.9'}, {'value': '40.3', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '148.9'}]}]}, {'title': 'OV: 24 months (n=5, 6)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.2'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '12.4'}]}]}, {'title': 'UV: 36 months (n=30, 18)', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '116.5'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '143.3'}]}]}, {'title': 'OV: 36 months (n=3, 2)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.2'}]}]}, {'title': 'UV: 6 months post-treatment (n=14, 16)', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '82.9'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '149.5'}]}]}, {'title': 'OV: 6 months post-treatment (n=2, 4)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '11.4'}]}]}, {'title': 'UV: 12 months post-treatment (n=42, 35)', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '96.1'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '91.1'}]}]}, {'title': 'OV: 12 months post-treatment (n=5, 4)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.9'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '5.3'}]}]}, {'title': 'UV: 24 months post-treatment (n=38, 28)', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '47.2'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '71.1'}]}]}, {'title': 'OV: 24 months post-treatment (n=4, 4)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.3'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter \\* transverse diameter \\* anteroposterior diameter of uterus)/(2\\*1000). Ovary volume = \\[(longitudinal diameter \\* transverse diameter \\* anteroposterior diameter of ovary) \\* 3.14\\]/(6\\*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.", 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'title': 'FIB: 6 months, BL Yes (n=60,50)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 6 months, BL No (n=60,50)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 6 months, BL Missing (n=60,50)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months, BL Yes (n=60,50)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months, BL No (n=60,50)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months, BL Missing (n=60,50)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months, BL Yes (n=61,52)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months, BL No (n=61,52)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months, BL Missing (n=61,52)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months, BL Yes (n=61,52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months, BL No (n=61,52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months, BL Missing (n=61,52)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months, BL Yes (n=61,52)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months, BL No (n=61,52)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months, BL Missing (n=61,52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months, BL Yes (n=61,52)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months, BL No (n=61,52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months, BL Missing (n=61,52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 36 months, BL Yes (n=33,18)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 36 months, BL No (n=33,18)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 36 months, BL Missing (n=33,18)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 36 months, BL Yes (n=33,18)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 36 months, BL No (n=33,18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 36 months, BL Missing (n=33,18)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 6 months post-treatment, BL Yes (n=16,17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 6 months post-treatment, BL No (n=16,17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 6 months post-treatment,BL Missing(n=16,17)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months post-treatment, BL Yes (n=16,17)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months post-treatment, BL No (n=16,17)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 6 months post-treatment,BL Missing(n=16,17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months post-treatment, BL Yes (n=51,38)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months post-treatment, BL No (n=51,38)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 12 months post-treatment, BL Missing(n=51,38)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months post-treatment, BL Yes (n=51,38)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months post-treatment, BL No (n=51,38)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 12 months post-treatment, BL Missing (n=51,38', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months post-treatment, BL Yes (n=43,31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months post-treatment, BL No (n=43,31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'FIB: 24 months post-treatment, BL Missing(n=43,31)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months post-treatment, BL Yes (n=43,31)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months post-treatment, BL No (n=43,31)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POL: 24 months post-treatment, BL Missing(n=43,31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.28', 'groupId': 'OG000'}, {'value': '21.28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post-treatment', 'description': 'Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Histological Findings: Endometrial Sub-study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'OG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'timeFrame': 'Baseline up to 24 months post-treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were not reported for this outcome measure because no data was collected as per change in planned analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'FG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2352'}, {'groupId': 'FG001', 'numSubjects': '2372'}]}, {'type': 'Treated', 'achievements': [{'comment': '8 participants randomized to receive exemestane, received tamoxifen. Reported as per randomization.', 'groupId': 'FG000', 'numSubjects': '2321'}, {'comment': '7 participants randomized to receive tamoxifen, received exemestane. Reported as per randomization.', 'groupId': 'FG001', 'numSubjects': '2337'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1810'}, {'groupId': 'FG001', 'numSubjects': '1830'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '542'}, {'groupId': 'FG001', 'numSubjects': '542'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'The publication describing study results (Coombes RC et al; N Engl J Med 350; 1119) stated that 4742 participants were enrolled in study. It was later discovered that 2 participants were randomized twice. Hence, 4740 participants were enrolled in this study.', 'preAssignmentDetails': 'Main study also included 3 sub-studies only for the purpose of tolerability assessment: endometrial status, bone metabolism and quality of life (QoL). Out of 4740 enrolled participants, data for 16 participants from a center were excluded since it was considered unreliable. Results are reported for remaining 4724 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2352', 'groupId': 'BG000'}, {'value': '2372', 'groupId': 'BG001'}, {'value': '4724', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exemestane', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'BG001', 'title': 'Tamoxifen', 'description': 'Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.78', 'spread': '8.12', 'groupId': 'BG000'}, {'value': '63.69', 'spread': '8.22', 'groupId': 'BG001'}, {'value': '63.73', 'spread': '8.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2352', 'groupId': 'BG000'}, {'value': '2372', 'groupId': 'BG001'}, {'value': '4724', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4740}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2002-05-31', 'resultsFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2002-05-31', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-05', 'studyFirstPostDateStruct': {'date': '2002-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study', 'timeFrame': 'Baseline up to Month 36', 'description': 'DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) at Month 36 Post-Randomization: Main Study', 'timeFrame': 'Baseline up to Month 120', 'description': "OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data."}, {'measure': 'Number of Events of Second Breast Cancer in Contralateral Breast: Main Study', 'timeFrame': 'Baseline up to Month 120', 'description': 'Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.'}, {'measure': 'Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \\[TH\\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment', 'description': "BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \\[TH\\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (\\>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (\\<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively."}, {'measure': 'Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment', 'description': "N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Number of Participants With Fracture: Bone Metabolism Sub-study', 'timeFrame': 'Baseline up to 24 months post-treatment'}, {'measure': 'Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version \\[FACT-B\\] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation."}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study', 'timeFrame': 'Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization', 'description': "The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Number of Participants With Severe Endocrine Symptoms: QoL Sub-study', 'timeFrame': 'Baseline up to 24 months after randomization', 'description': 'Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.'}, {'measure': 'Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Endometrial Thickness: Endometrial Sub-study', 'timeFrame': 'Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Uterine and Overall Ovary Volume: Endometrial Sub-study', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter \\* transverse diameter \\* anteroposterior diameter of uterus)/(2\\*1000). Ovary volume = \\[(longitudinal diameter \\* transverse diameter \\* anteroposterior diameter of ovary) \\* 3.14\\]/(6\\*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'measure': 'Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study', 'timeFrame': '6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment', 'description': "Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline."}, {'measure': 'Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study', 'timeFrame': 'Baseline up to 24 months post-treatment', 'description': 'Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.'}, {'measure': 'Number of Participants With Histological Findings: Endometrial Sub-study', 'timeFrame': 'Baseline up to 24 months post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96-OEXE-031&StudyName=Randomized%20Trial%20Of%20Exemestane%20Versus%20Continued%20Tamoxifen%20In%20Postmenopausal%20Women%20With%20Early%20Breast%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease\n\nExclusion Criteria:\n\n* unresectable breast cancer\n* ER negative primary tumor'}, 'identificationModule': {'nctId': 'NCT00038467', 'acronym': 'IES', 'briefTitle': 'Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen', 'orgStudyIdInfo': {'id': '96-OEXE-031'}, 'secondaryIdInfos': [{'id': 'A5991012'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Tamoxifen']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Exemestane']}], 'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG', 'description': 'Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.', 'armGroupLabels': ['B']}, {'name': 'Exemestane', 'type': 'DRUG', 'description': 'Exemestane 25 mg/day tablets administered 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