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Ignite Creation Date: 2025-12-25 @ 2:17 AM

Ignite Modification Date: 2025-12-27 @ 10:50 PM

Study NCT ID: NCT00833560

Status: COMPLETED

Last Update Posted: 2014-11-21

First Post: 2009-01-23

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

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': '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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+49 2137 955-492', 'title': 'Therapeutic Areas Director', 'organization': 'Jan-Cil Germany'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles', 'otherNumAtRisk': 395, 'otherNumAffected': 392, 'seriousNumAtRisk': 395, 'seriousNumAffected': 103}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 105, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 85, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 70, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 46, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 32, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 75, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 62, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 68, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 55, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 50, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 47, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 43, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 73, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 56, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 38, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 39, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 49, 'numAffected': 45}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 53, 'numAffected': 46}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 680, 'numAffected': 211}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 277, 'numAffected': 129}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 132, 'numAffected': 77}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 53, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 141, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 98, 'numAffected': 86}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 88, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 63, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Encephalitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hyperviscosity syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Intestinal dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Blood immunoglobulin G increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Alveolitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Epiglottic oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Percentage of participants with response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.4', 'ciLowerLimit': '81.5', 'ciUpperLimit': '88.8', 'statisticalMethod': 'Two - sided binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 63', 'description': 'CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).'}, {'type': 'SECONDARY', 'title': 'Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Percentage of participants with response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.7', 'ciLowerLimit': '83.6', 'ciUpperLimit': '91.0', 'statisticalMethod': 'Two-sided binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 63', 'description': 'CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'classes': [{'title': '13q- (n=112)', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': 't (4;14) (n=38)', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}]}]}, {'title': '17p- (n=31)', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=104)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}, {'title': 'No changes (n=102)', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 63', 'description': 'Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'classes': [{'title': '13q- (n=92)', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 't (4;14) (n=34)', 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}]}]}, {'title': '17p- (n=24)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=87)', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}]}]}, {'title': 'No changes (n=87)', 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 63', 'description': 'Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregression of other disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': '401 participants were enrolled at 41 study sites in Germany.', 'preAssignmentDetails': 'Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m\\^2 per cycle in Part 1 were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 20 and 39 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Between 40 and 49 years', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}, {'title': 'Between 50 and 60 years', 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-11', 'studyFirstSubmitDate': '2009-01-23', 'resultsFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-15', 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)', 'timeFrame': 'Up to Day 63', 'description': 'CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.'}], 'secondaryOutcomes': [{'measure': 'Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)', 'timeFrame': 'Up to Day 63', 'description': 'CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.'}, {'measure': 'Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)', 'timeFrame': 'Up to Day 63', 'description': 'Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible'}, {'measure': 'Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)', 'timeFrame': 'Up to Day 63', 'description': 'Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Untreated multiple myeloma', 'Bortezomib', 'VELCADE', 'Cyclophosphamide', 'Dexamethasone', 'Chemotherapy', 'Remission therapy', 'Induction therapy', 'Stem Cell Transplantation'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.', 'detailedDescription': 'This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cytologically or histologically diagnosed with multiple myeloma stage II/III\n* Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)\n* Agree to use one of the contraception methods as defined in the protocol\n* Karnofsky performance status 60 percent or more\n* Adequate laboratory test values\n\nExclusion Criteria:\n\n* Non-secretory multiple myeloma\n* Estimated life expectancy less than 3 months\n* History of cancer (except basal cell carcinoma) in the last 5 years\n* Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more\n* Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C\n* Pregnant or breast-feeding female participants'}, 'identificationModule': {'nctId': 'NCT00833560', 'briefTitle': 'A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag G.m.b.H'}, 'officialTitle': 'Clinical Study on Induction of Remission Using Bortezomib (Vel), Cyclophosphamide (C), and Dexamethasone (D) in Patients Until 60 Years of Age With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy: (VelCD; Deutsche Studiengruppe Multiples Myelom [DSMM] XIa)', 'orgStudyIdInfo': {'id': 'CR005242'}, 'secondaryIdInfos': [{'id': '26866138MMY2031', 'type': 'OTHER', 'domain': 'Janssen-Cilag G.m.b.H, Germany'}, {'id': '2005-003902-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclophosphamide + Bortezomib + Dexamethasone', 'description': 'Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Bortezomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.', 'armGroupLabels': ['Cyclophosphamide + Bortezomib + Dexamethasone']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['VELCADE'], 'description': 'Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).', 'armGroupLabels': ['Cyclophosphamide + Bortezomib + Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).', 'armGroupLabels': ['Cyclophosphamide + Bortezomib + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berg', 'country': 'Germany', 'geoPoint': {'lat': 49.81417, 'lon': 12.14161}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bremen', 'country': 'Germany', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Greifswald', 'country': 'Germany', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Halle', 'country': 'Germany', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamm', 'country': 'Germany', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Homburg', 'country': 'Germany', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Jena', 'country': 'Germany', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Karlsruhe', 'country': 'Germany', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Lübeck', 'country': 'Germany', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Magdeburg', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Mainz', 'country': 'Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Mutlangen', 'country': 'Germany', 'geoPoint': {'lat': 48.82588, 'lon': 9.79714}}, {'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Nuremberg', 'country': 'Germany', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Oldenburg', 'country': 'Germany', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'city': 'Potsdam', 'country': 'Germany', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Rehling', 'country': 'Germany', 'geoPoint': {'lat': 48.48333, 'lon': 10.93333}}, {'city': 'Rostock', 'country': 'Germany', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Stuttgart', 'country': 'Germany', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Villingen-Schwenningen', 'country': 'Germany', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'city': 'Würzburg', 'country': 'Germany', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Janssen-Cilag G.m.b.H, Germany Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag G.m.b.H'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag G.m.b.H', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}