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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 12:43 AM

Ignite Modification Date: 2025-12-27 @ 12:44 PM

Study NCT ID: NCT00242567

Status: COMPLETED

Last Update Posted: 2014-05-07

First Post: 2005-10-19

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.\n\nThe terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Early Group', 'description': 'Early Group', 'otherNumAtRisk': 259, 'otherNumAffected': 220, 'seriousNumAtRisk': 259, 'seriousNumAffected': 121}, {'id': 'EG001', 'title': 'Delayed Group (Overall)', 'description': 'Delayed Group (Overall)', 'otherNumAtRisk': 263, 'otherNumAffected': 197, 'seriousNumAtRisk': 263, 'seriousNumAffected': 104}, {'id': 'EG002', 'title': 'Delayed Group (No Zometa)', 'description': 'Delayed Group (No Zometa)', 'otherNumAtRisk': 191, 'otherNumAffected': 135, 'seriousNumAtRisk': 191, 'seriousNumAffected': 67}, {'id': 'EG003', 'title': 'Delayed Group (Zometa)', 'description': 'Delayed Group (Zometa)', 'otherNumAtRisk': 72, 'otherNumAffected': 62, 'seriousNumAtRisk': 72, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PROSTATIC SPECIFIC ANTIGEN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULOSKELETAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULOSKELETAL STIFFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'METASTATIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DEPRESSED MOOD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSURIA', 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN IN JAW', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': 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'MedDRA'}, {'term': 'BRAIN NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BRONCHIAL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEAD AND NECK CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 2}, {'groupId': 'EG001', 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'sourceVocabulary': 'MedDRA'}, {'term': 'METASTATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'METASTATIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EMPHYSEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HAEMORRHAGE SUBCUTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TRANSURETHRAL PROSTATECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EXTRINSIC VASCULAR COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'OG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'classes': [{'title': 'Patients with event (s)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Patients without event (censored)', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population will consist of all patients randomized to treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 18 Months and 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'OG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'classes': [{'title': 'Patients with event (s) - 18 months', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Patients without event - 18 months', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}, {'title': 'Patients with event (s) - 36 months', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Patients without event - 36 months', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'month 18, year 3', 'description': 'Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population will consist of all patients randomized to treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Skeletal Related Event or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'OG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 18 months', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 18 months', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '18 Months', 'description': 'Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population consisted of all patients randomized to treatment.'}, {'type': 'SECONDARY', 'title': 'Skeletal-related Event(SRE)-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'OG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE at 36 months', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE at 36 months', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 months', 'description': 'Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population consisted of all patients randomized to treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Skeletal Related Event or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'OG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 36 months', 'groupId': 'OG000', 'lowerLimit': '945', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 36 months', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 Months', 'description': 'Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population consisted of all patients randomized to treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'FG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Never Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Symptomatic deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Use of an inhibitor of bone resorption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': '552 patients enrolled, but 30 patients were excluded due to GCP issues in one country.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.'}, {'id': 'BG001', 'title': 'Delayed Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.4', 'spread': '8.46', 'groupId': 'BG000'}, {'value': '70.2', 'spread': '8.26', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '8.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2005-10-19', 'resultsFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-29', 'studyFirstPostDateStruct': {'date': '2005-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer', 'timeFrame': '18 months', 'description': 'Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival at 18 Months and 3 Years', 'timeFrame': 'month 18, year 3', 'description': 'Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.'}, {'measure': 'Time to Occurrence of Skeletal Related Event or Death', 'timeFrame': '18 Months', 'description': 'Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.'}, {'measure': 'Skeletal-related Event(SRE)-Free Survival', 'timeFrame': '36 months', 'description': 'Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.'}, {'measure': 'Time to Occurrence of Skeletal Related Event or Death', 'timeFrame': '36 Months', 'description': 'Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.'}]}, 'conditionsModule': {'keywords': ['zoledronic acid', 'bone metastases', 'prostate cancer', 'hormone-sensitive'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate cancer\n* at least one bone metastasis\n* receiving or about to receive androgen deprivation therapy (ADT)\n\nExclusion Criteria:\n\n* previous ADT failure\n* previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy\n* abnormal renal function\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00242567', 'briefTitle': 'Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.', 'orgStudyIdInfo': {'id': 'CZOL446E2432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.', 'interventionNames': ['Drug: Zoledronic Acid']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed group', 'description': 'Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level.', 'interventionNames': ['Drug: Androgen Deprivation Therapy (ADT)']}], 'interventions': [{'name': 'Zoledronic Acid', 'type': 'DRUG', 'description': 'Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.\n\nAfter addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.\n\nThe infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes.', 'armGroupLabels': ['Early Group']}, {'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG', 'description': 'Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.', 'armGroupLabels': ['Delayed group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Brisbane', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Port Macquarie', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}, {'city': 'Sydney', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Santo André', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Kyunggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}