Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-01 @ 3:22 AM
Study NCT ID:
NCT00104104
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2005-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multiple Myeloma Trial in Patients With Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novatis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The 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 the pooled data (i.e., data from all sites) in the clinical trial; or disclosure of the trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Because of GCP violations at Site 74, post-baseline data from that site are excluded from analyses, leaving 85 patients in the 15-minute infusion group and 84 patients in the 30-minute infusion group.', 'eventGroups': [{'id': 'EG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.', 'otherNumAtRisk': 85, 'otherNumAffected': 74, 'seriousNumAtRisk': 85, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.', 'otherNumAtRisk': 84, 'otherNumAffected': 76, 'seriousNumAtRisk': 84, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Jugular vein distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'OG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '2.65'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '2.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 Months', 'description': 'The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'OG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '2.13'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '2.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 24 Months', 'description': 'Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; enrolled patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time to First Significant Increase in Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'OG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '19.88', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '65.0'}, {'value': '24.4', 'spread': '31.48', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '93.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Median time to event in participants who had a clinically relevant increase in serum creatinine.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.'}, {'type': 'SECONDARY', 'title': 'Zoledronic Acid Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'OG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'classes': [{'title': 'First Collection (10 minutes, 25 minutes)', 'categories': [{'measurements': [{'value': '231.1', 'spread': '185.4', 'groupId': 'OG000'}, {'value': '186.3', 'spread': '54.4', 'groupId': 'OG001'}]}]}, {'title': 'Second Collection (15 minutes, 30 minutes)', 'categories': [{'measurements': [{'value': '248.8', 'spread': '92.0', 'groupId': 'OG000'}, {'value': '172.0', 'spread': '48.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'The Number of Participants With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'OG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; enrolled patients who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'FG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 Participants in the 15-minute infusion group did not receive study drug.', 'groupId': 'FG000', 'numSubjects': '90'}, {'comment': '1 Participants in the 30-minute infusion group did not receive study drug.', 'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Safety Population (Including Site 74)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Safety Population (Excluding Site 74)', 'achievements': [{'comment': 'Because of GCP violations at Site 74, post-baseline data for 3 patients in this arm were excluded.', 'groupId': 'FG000', 'numSubjects': '85'}, {'comment': 'Because of GCP violations at Site 74, post-baseline data for 4 patients in this arm were excluded.', 'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Condition no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '15 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.'}, {'id': 'BG001', 'title': '30 - Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Demographic data is provided for the entire Safety Population.', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '11.95', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '11.54', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time since diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '24.3', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '11.1', 'spread': '19.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This baseline measurement was based on n=86, 87.', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calculated creatinine clearance', 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'spread': '32.6', 'groupId': 'BG000'}, {'value': '89.3', 'spread': '39.5', 'groupId': 'BG001'}, {'value': '88.3', 'spread': '36.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2005-02-22', 'resultsFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2005-02-22', 'lastUpdatePostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-04', 'studyFirstPostDateStruct': {'date': '2005-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months', 'timeFrame': 'Baseline and 12 Months', 'description': 'The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.'}, {'measure': 'The Number of Participants With Disease Progression', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months', 'timeFrame': 'Baseline and 24 Months', 'description': 'Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.'}, {'measure': 'Time to First Significant Increase in Serum Creatinine', 'timeFrame': 'Up to 24 months', 'description': 'Median time to event in participants who had a clinically relevant increase in serum creatinine.'}, {'measure': 'Zoledronic Acid Concentrations', 'timeFrame': '24 months', 'description': 'Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.'}]}, 'conditionsModule': {'keywords': ['Z-MAX, multiple myeloma, zoledronic acid, bone metastases'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com', 'label': 'Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Confirmed diagnosis of Multiple Myeloma\n* Stable renal function defined as two serum creatinine determinations of \\< 3 mg/dL\n* Calculated creatinine clearance of greater than or equal to 30 mL/min\n* ECOG Performance Status of 0 or 1\n* Life expectancy of greater than or equal to 9 months\n* If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.\n* Ability to comply with trial requirements and give informed consent.\n\nExclusion Criteria:\n\n* IV Bisphosphonate therapy for more than 3 years.\n* Patients with a diagnosis of amyloidosis.\n* Known hypersensitivity to zoledronic acid or other bisphosphonates\n* Pregnant patients or lactating patients.\n* Women of childbearing potential not on a medically recognized form of contraception\n* Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT00104104', 'briefTitle': 'A Multiple Myeloma Trial in Patients With Bone Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases', 'orgStudyIdInfo': {'id': 'CZOL446EUS97'}, 'secondaryIdInfos': [{'id': 'US97'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks', 'interventionNames': ['Drug: zoledronic acid']}, {'type': 'EXPERIMENTAL', 'label': '30 Minute Infusion', 'description': 'Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.', 'interventionNames': ['Drug: zoledronic acid']}], 'interventions': [{'name': 'zoledronic acid', 'type': 'DRUG', 'otherNames': ['ZOMETA®'], 'description': '4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.', 'armGroupLabels': ['15 Minute Infusion', '30 Minute Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Hematology Oncology Specialists', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Hematology Oncology', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'US Oncology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Myeloma Institute For Research Therapy', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Southbay Oncology Hematology Partners', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Oncology of the Central Valley', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Robert P. Brouillard Inc.', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Antelope Valley Cancer Center', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'North Valley H/O', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Hematology/Oncology Group of Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Camino Medical Group', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Oncotherapeutics', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'Greeley Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '33901', 'city': 'Fort Meyers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists'}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Oncology Hematology', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Osceola Cancer Center', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Hernado Oncology', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'MetCare Oncology', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '32501', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology Oncology Associates PA', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '32955', 'city': 'Rockledge', 'state': 'Florida', 'country': 'United States', 'facility': 'Hem/Onc Associates of Central Brevard', 'geoPoint': {'lat': 28.35084, 'lon': -80.72533}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Oncology Associates', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30084', 'city': 'Tucker', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists', 'geoPoint': {'lat': 33.85455, 'lon': -84.21714}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cancer Care Center', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hutchinson Clinic, PA', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology and Oncology Specialists', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Center for Cancer Medicine - Blood Disorders', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20735', 'city': 'Clinton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Oncology Hematology Associates, PA', 'geoPoint': {'lat': 38.76511, 'lon': -76.89831}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Oncology-Hematology PA', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '48144', 'city': 'Lambertville', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Ohio & Michigan', 'geoPoint': {'lat': 41.76588, 'lon': -83.62799}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Providence Cancer Center, Clinical Trials Dept', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '64131', 'city': 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