Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 9:59 AM
Study NCT ID:
NCT00433160
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2007-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Clinical Trial of Teriparatide in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added'}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Teriparatide (During 52 Weeks)', 'description': '20 micrograms for 104 weeks', 'otherNumAtRisk': 136, 'otherNumAffected': 115, 'seriousNumAtRisk': 136, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo (During 52 Weeks)', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks', 'otherNumAtRisk': 67, 'otherNumAffected': 59, 'seriousNumAtRisk': 67, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Teriparatide (During 76 Weeks)', 'description': '20 micrograms for 104 weeks', 'otherNumAtRisk': 136, 'otherNumAffected': 123, 'seriousNumAtRisk': 136, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Placebo (During 76 Weeks)', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks', 'otherNumAtRisk': 67, 'otherNumAffected': 60, 'seriousNumAtRisk': 67, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Teriparatide (During 104 Weeks)', 'description': '20 micrograms for 104 weeks', 'otherNumAtRisk': 136, 'otherNumAffected': 125, 'seriousNumAtRisk': 136, 'seriousNumAffected': 12}, {'id': 'EG005', 'title': 'Placebo (During 104 Weeks)', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks', 'otherNumAtRisk': 67, 'otherNumAffected': 64, 'seriousNumAtRisk': 67, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 66, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 37, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 89, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 51, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 113, 'numAffected': 55}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 68, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG005', 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 22, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 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'MedDRA 12.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopulmonary aspergillosis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Brachial plexus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Last Measurement Point', 'categories': [{'measurements': [{'value': '9.82', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '4.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 52 weeks', 'description': 'Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Last Measurement Point', 'categories': [{'measurements': [{'value': '10.23', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '4.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Last Measurement Point', 'categories': [{'measurements': [{'value': '2.66', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '3.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Last Measurement Point', 'categories': [{'measurements': [{'value': '2.24', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '3.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density at femoral neck from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 4 (n=136, n=66)', 'categories': [{'measurements': [{'value': '90.67', 'spread': '49.85', 'groupId': 'OG000'}, {'value': '-9.58', 'spread': '14.39', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 12 (n=131, n=64)', 'categories': [{'measurements': [{'value': '89.58', 'spread': '66.58', 'groupId': 'OG000'}, {'value': '-16.89', 'spread': '17.35', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 24 (n=127, n=61)', 'categories': [{'measurements': [{'value': '114.12', 'spread': '112.04', 'groupId': 'OG000'}, {'value': '-19.10', 'spread': '29.17', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 52 (n=121, n=60)', 'categories': [{'measurements': [{'value': '116.11', 'spread': '139.72', 'groupId': 'OG000'}, {'value': '-14.18', 'spread': '29.02', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Last Measurement (n=136,n=66)', 'categories': [{'measurements': [{'value': '111.74', 'spread': '134.38', 'groupId': 'OG000'}, {'value': '-13.82', 'spread': '28.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 4, 12, 24, and 52', 'description': 'Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in PINP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 4 (n=135, n=66)', 'categories': [{'measurements': [{'value': '3.74', 'spread': '37.86', 'groupId': 'OG000'}, {'value': '-9.63', 'spread': '33.62', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 12 (n=131, n=62)', 'categories': [{'measurements': [{'value': '3.23', 'spread': '49.05', 'groupId': 'OG000'}, {'value': '-16.97', 'spread': '40.54', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 24 (n=127, n=60)', 'categories': [{'measurements': [{'value': '-4.60', 'spread': '43.44', 'groupId': 'OG000'}, {'value': '-28.46', 'spread': '23.81', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 52 (n=120, n=59)', 'categories': [{'measurements': [{'value': '-17.69', 'spread': '58.12', 'groupId': 'OG000'}, {'value': '-32.24', 'spread': '46.95', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Last Measurement (n=136, n=66)', 'categories': [{'measurements': [{'value': '-17.32', 'spread': '56.06', 'groupId': 'OG000'}, {'value': '-28.34', 'spread': '46.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.', 'statisticalMethod': "Wicoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 4, 12, 24, 52', 'description': 'Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in BAP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 4 (n=124, n=63)', 'categories': [{'measurements': [{'value': '2.78', 'spread': '40.73', 'groupId': 'OG000'}, {'value': '-2.05', 'spread': '28.17', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 12 (n=121, n=61)', 'categories': [{'measurements': [{'value': '46.52', 'spread': '69.52', 'groupId': 'OG000'}, {'value': '-3.56', 'spread': '27.90', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 24 (n=119, n=59)', 'categories': [{'measurements': [{'value': '82.27', 'spread': '110.54', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '37.97', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 52 (n=113, n=58)', 'categories': [{'measurements': [{'value': '84.81', 'spread': '124.23', 'groupId': 'OG000'}, {'value': '13.50', 'spread': '39.47', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Last Measurement (n=126, n=65)', 'categories': [{'measurements': [{'value': '79.41', 'spread': '119.61', 'groupId': 'OG000'}, {'value': '11.64', 'spread': '38.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.976', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.', 'groupDescription': 'Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.', 'statisticalMethod': "Wilcoxon's Rank Sum Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 4, 12, 24, 52', 'description': 'Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in CTX', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Vertebral Fractures by Central X-ray Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'New Fractures (n=5, n=4)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Worsening Fractures (n=2, n=0)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.', 'unitOfMeasure': 'number of fractures', 'reportingStatus': 'POSTED', 'populationDescription': "Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures."}, {'type': 'SECONDARY', 'title': 'Fractures by Investigators Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Vertebral Fracture - Fragility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vertebral Fracture - Traumatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Non-Vertebra Fracture - Fragility', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Non-Vertebra Fracture - Traumatic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 Weeks', 'description': 'Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.', 'unitOfMeasure': 'number of fractures', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Back Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Baseline: 1 - None', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 - Mild', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 3 - Moderate', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 1 - None', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 - Mild', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 3 - Moderate', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 1 - None', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 - Mild', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 3 - Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: 1 - None', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: 2 - Mild', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: 3 - Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 1 - None', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 2 - Mild', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 3 - Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Last Measurement: 1 - None', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Last Measurement: 2 - Mild', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Last Measurement: 3 - Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Last Measurement: 4 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 52', 'description': 'Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=113, n=55', 'categories': [{'measurements': [{'value': '11.93', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '6.39', 'spread': '4.74', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=92, n=47', 'categories': [{'measurements': [{'value': '13.42', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '9.11', 'spread': '5.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=113, n=55', 'categories': [{'measurements': [{'value': '12.24', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '6.63', 'spread': '4.69', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=92, n=47', 'categories': [{'measurements': [{'value': '14.01', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '9.46', 'spread': '5.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=112, n=54', 'categories': [{'measurements': [{'value': '3.02', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '4.63', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=91, n=46', 'categories': [{'measurements': [{'value': '3.67', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=112, n=54', 'categories': [{'measurements': [{'value': '2.68', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '4.81', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=91, n=46', 'categories': [{'measurements': [{'value': '3.26', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '4.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density at femoral neck from baseline to the last measurement point.', 'unitOfMeasure': 'percent change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent change to Week 76; n=113, n=55', 'categories': [{'measurements': [{'value': '115.45', 'spread': '174.07', 'groupId': 'OG000'}, {'value': '97.28', 'spread': '131.64', 'groupId': 'OG001'}]}]}, {'title': 'Percent change to Week 104; n=92, n=47', 'categories': [{'measurements': [{'value': '74.71', 'spread': '112.48', 'groupId': 'OG000'}, {'value': '134.89', 'spread': '180.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in PINP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=113, n=55', 'categories': [{'measurements': [{'value': '17.49', 'spread': '66.40', 'groupId': 'OG000'}, {'value': '15.71', 'spread': '64.96', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=92, n=47', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '54.38', 'groupId': 'OG000'}, {'value': '16.45', 'spread': '71.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in BAP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Percent Change to Week 76; n=104, n=53', 'categories': [{'measurements': [{'value': '85.85', 'spread': '137.13', 'groupId': 'OG000'}, {'value': '86.98', 'spread': '132.81', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change to Week 104; n=85, n=45', 'categories': [{'measurements': [{'value': '54.39', 'spread': '111.97', 'groupId': 'OG000'}, {'value': '72.84', 'spread': '100.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.', 'unitOfMeasure': 'percent change in CTX', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'New Fractures at 104 Weeks (n=5, n=6)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Worsening Fractures at 104 Weeks (n=2, n=2)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 104 Weeks', 'description': 'Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.', 'unitOfMeasure': 'number of fractures', 'reportingStatus': 'POSTED', 'populationDescription': "Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.", 'anticipatedPostingDate': '2010-10'}, {'type': 'SECONDARY', 'title': 'Fractures by Investigators Assessment During Entire Study Period of 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Vertebral Fracture - Fragility - 104 Weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vertebral Fracture - Traumatic - 104 Weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Non-Vertebra Fracture - Fragility - 104 Weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Non-Vertebra Fracture - Traumatic - 104 Weeks', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Through 104 Weeks', 'description': 'Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.', 'unitOfMeasure': 'number of fractures', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'classes': [{'title': 'Week 76: 1- None', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 76: 2- Mild', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 76: 3- Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 76: 4- Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 1- None', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 2- Mild', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 3- Moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 4- Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.', 'anticipatedPostingDate': '2010-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}], 'periods': [{'title': '52-Week Double-Blind (DB) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '76 Weeks, 24-Week Open Label (OL) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant did not continue to first OL period due to adverse event after completing DB period.', 'groupId': 'FG000', 'numSubjects': '119'}, {'comment': 'One participant did not continue to first OL period due to adverse event after completing DB period.', 'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '104 Weeks, 28-Week OL Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eleven participants withdrew at end of first OL period and did not continue on to second OL period.', 'groupId': 'FG000', 'numSubjects': '102'}, {'comment': 'Five participants withdrew at end of first OL period and did not continue on to second OL period.', 'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Teriparatide', 'description': '20 micrograms for 104 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '70.4', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '69.6', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Previous Vertebral Fractures', 'classes': [{'title': '0 Fractures', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': '1 Fracture', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': '2 Fractures', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '3 Fractures', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '4 Fractures', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '5 or More Fractures', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Osteoporosis Drug Use', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking History', 'classes': [{'title': 'Non-Smoker', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Past Smoker', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '21.58', 'spread': '3.03', 'groupId': 'BG000'}, {'value': '22.24', 'spread': '3.34', 'groupId': 'BG001'}, {'value': '21.80', 'spread': '3.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared (kg/m\\^2).', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bone Mineral Density (BMD) Total Spine', 'classes': [{'categories': [{'measurements': [{'value': '0.6153', 'spread': '0.0701', 'groupId': 'BG000'}, {'value': '0.6123', 'spread': '0.0780', 'groupId': 'BG001'}, {'value': '0.6143', 'spread': '0.0726', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams per square centimeter (g/cm^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '150.40', 'spread': '5.97', 'groupId': 'BG000'}, {'value': '150.30', 'spread': '5.74', 'groupId': 'BG001'}, {'value': '150.36', 'spread': '5.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '48.74', 'spread': '6.83', 'groupId': 'BG000'}, {'value': '50.25', 'spread': '8.10', 'groupId': 'BG001'}, {'value': '49.24', 'spread': '7.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-14', 'studyFirstSubmitDate': '2007-02-07', 'resultsFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2007-02-07', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-21', 'studyFirstPostDateStruct': {'date': '2007-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)', 'timeFrame': 'Baseline to 52 weeks', 'description': 'Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at Total Hip', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at Femoral Neck', 'timeFrame': 'Baseline to 52 Weeks', 'description': 'Percent change in bone mineral density at femoral neck from baseline to the last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)', 'timeFrame': 'Baseline to Weeks 4, 12, 24, and 52', 'description': 'Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)', 'timeFrame': 'Baseline to Weeks 4, 12, 24, 52', 'description': 'Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)', 'timeFrame': 'Baseline to Weeks 4, 12, 24, 52', 'description': 'Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.'}, {'measure': 'Vertebral Fractures by Central X-ray Assessment', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.'}, {'measure': 'Fractures by Investigators Assessment', 'timeFrame': 'Baseline through 52 Weeks', 'description': 'Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.'}, {'measure': 'Back Pain Severity', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 52', 'description': 'Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).'}, {'measure': 'Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in bone mineral density at femoral neck from baseline to the last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.'}, {'measure': 'Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.'}, {'measure': 'Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks', 'timeFrame': 'Baseline through 104 Weeks', 'description': 'Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.'}, {'measure': 'Fractures by Investigators Assessment During Entire Study Period of 104 Weeks', 'timeFrame': 'Baseline Through 104 Weeks', 'description': 'Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.'}, {'measure': 'Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks', 'timeFrame': 'Baseline, 76 Weeks, 104 Weeks', 'description': 'Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).'}]}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '20580870', 'type': 'RESULT', 'citation': 'Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.'}, {'pmid': '26185429', 'type': 'DERIVED', 'citation': 'Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese patients diagnosed with osteoporosis\n* Aged 55 or older\n* Patients who are at high risk for fracture\n\nExclusion Criteria:\n\n* History of metabolic bone disorders other than primary osteoporosis\n* History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.\n* Severe or chronically disabling conditions other than osteoporosis'}, 'identificationModule': {'nctId': 'NCT00433160', 'briefTitle': 'Phase 3 Clinical Trial of Teriparatide in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis', 'orgStudyIdInfo': {'id': '10494'}, 'secondaryIdInfos': [{'id': 'B3D-JE-GHDB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teriparatide', 'description': '20 micrograms for 104 weeks', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks', 'interventionNames': ['Drug: Teriparatide', 'Drug: Placebo']}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['LY333334', 'Forteo', 'Forsteo'], 'description': 'daily, subcutaneous', 'armGroupLabels': ['Placebo', 'Teriparatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'daily, subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '454-0933', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '811-2101', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '070-0034', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '655-0853', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '890-0014', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '231-0023', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '386-0493', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '854-0083', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '020-8505', 'city': 'Numakunai', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'zip': '555-0032', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '879-7125', 'city': 'Ōita', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '358-0007', 'city': 'Saitama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '693-0021', 'city': 'Shimane', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'zip': '770-8503', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '163-0202', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '683-0853', 'city': 'Tottori', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}