Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-04 @ 1:43 PM
Study NCT ID:
NCT00617669
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2008-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway', 'Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C511404', 'term': 'ZD4054'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': '3\\. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.\n\nAstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed to allow for', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks', 'otherNumAtRisk': 522, 'otherNumAffected': 490, 'seriousNumAtRisk': 522, 'seriousNumAffected': 214}, {'id': 'EG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks', 'otherNumAtRisk': 525, 'otherNumAffected': 483, 'seriousNumAtRisk': 525, 'seriousNumAffected': 203}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 118}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 60}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 36}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 185}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 160}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 129}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 278}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 188}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 119}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 91}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 84}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 71}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 59}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 72}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 78}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 196}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 40}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nail Discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nail Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphatic Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aortic Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diastolic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertrophic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Adrenocortical Insufficiency Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Inappropriate Antidiuretic Hormone Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Scleral Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphyloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colonic Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erosive Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Inguinal Hernia Strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Large Intestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mouth Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenic Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophagitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectourethral Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Medical Device Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Device Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bacterial Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Catheter Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lyme Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Necrotising Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumocystis Jiroveci Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psoas Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral Haemorrhage Traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Kidney Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiple Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postoperative Wound Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Radiation Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stress Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toxicity To Various Agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wrist Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood Electrolytes Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Electrocardiogram QT Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteonecrosis Of Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder Transitional Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colorectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal Stromal Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lentigo Maligna Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malignant Lymphoid Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depressed Level Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal Cord Compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder Neck Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus Ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis Noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhage Urinary Tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postrenal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Tubular Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stevens-Johnson Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femoral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'sThrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '32.0'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '30.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients were followed for survival up to 40 months', 'description': 'Median time (in months) from randomisation until death using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '13.1'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients were followed for progression up to 40 months', 'description': 'Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Incidence of Skeletal Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '25.3'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Prostate-specific Antigen (PSA) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '19.6'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '18.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until first PSA value \\>50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '18.4'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '18.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Pain Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '10.7'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'PSA response defined as \\>50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'FG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '524'}, {'groupId': 'FG001', 'numSubjects': '528'}]}, {'type': 'Patients Who Received IP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '522'}, {'groupId': 'FG001', 'numSubjects': '525'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients receiving ZD4054 10 mg at data cut-off', 'groupId': 'FG000', 'numSubjects': '94'}, {'comment': 'Patients receiving placebo at data cut-off', 'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '451'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Reason not otherwise captured, eg; death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'Patients randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '1494 patients with hormone resistant prostate cancer patients and bone metastasis were recruited between 24th January 2008 and 10th May 2011', 'preAssignmentDetails': '442 of the 1494 enrolled patients were not randomised to treatment groups as they failed screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '528', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ZD4054 + Docetaxel', 'description': 'XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'BG001', 'title': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'overall', 'categories': [{'measurements': [{'value': '8.1', 'spread': '67.7', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '67.6', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '67.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '524', 'groupId': 'BG000'}, {'value': '528', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1494}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2008-01-24', 'resultsFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-26', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Patients were followed for survival up to 40 months', 'description': 'Median time (in months) from randomisation until death using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Patients were followed for progression up to 40 months', 'description': 'Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline'}, {'measure': 'Incidence of Skeletal Related Events', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.'}, {'measure': 'Time to Prostate-specific Antigen (PSA) Progression', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until first PSA value \\>50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.'}, {'measure': 'Time to Pain Progression', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.'}, {'measure': 'Pain Response', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.'}, {'measure': 'PSA Response', 'timeFrame': 'While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)', 'description': 'PSA response defined as \\>50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hormone Resistant Prostate Cancer', 'Endothelin A Receptor Antagonist', 'Endothelin A', 'Endothelin A antagonist'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '23569308', 'type': 'DERIVED', 'citation': 'Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).\n\nThis clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.\n\nZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.\n\nAll patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.\n\nHalf the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.\n\nNo patients will be deprived of standard prostate cancer therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who answer TRUE to the following criteria may be eligible to participate in this trial.\n\n* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)\n* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment\n* Currently receiving treatment with surgical or medical castration\n\nExclusion Criteria:\n\nPatients who answer TRUE to the following ARE NOT eligible to participate in this trial.\n\n* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.\n* Suffering from heart failure or had a myocardial infarction within last 6 months\n* A history of epilepsy or seizures'}, 'identificationModule': {'nctId': 'NCT00617669', 'acronym': 'ENTHUSE M1C', 'briefTitle': 'A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'D4320C00033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Docetaxel', 'description': 'placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks', 'interventionNames': ['Drug: Docetaxel', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ZD4054 + Docetaxel', 'description': 'ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks', 'interventionNames': ['Drug: Docetaxel', 'Drug: ZD4054']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere®'], 'description': 'intravenous infusion given every three weeks', 'armGroupLabels': ['Placebo + Docetaxel', 'ZD4054 + Docetaxel']}, {'name': 'ZD4054', 'type': 'DRUG', 'otherNames': ['Zibotentan'], 'description': '10 mg oral once daily dose', 'armGroupLabels': ['ZD4054 + Docetaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo oral tablet once daily', 'armGroupLabels': ['Placebo + Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'PORTUGALt Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Bahía Blanca', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site'}, {'city': 'Santa Fe', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Redcliffe', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.22649, 'lon': 153.10648}}, {'city': 'Ashford', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.94859, 'lon': 138.57457}}, {'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'city': 'Wodonga', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -36.12179, 'lon': 146.88809}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'city': 'Fortaleza', 'state': 'Ceara/ LA', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Goiânia', 'state': 'Goias/ LA', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Belo Horizonte', 'state': 'Minas GERMANYais', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Curitiba', 'state': 'Parana/ Brazil', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'PORTUGALto Alegre', 'state': 'Rio Grande Do Sul/ LA', 'country': 'Brazil', 'facility': 'Research Site'}, {'city': 'Ribeirão Preto', 'state': 'Sao Paulo/ LA', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Olomouc', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Ústí nad Labem', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Brno', 'state': 'Czechoslovakia Republic', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Jablonec nad Nisou', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.72431, 'lon': 15.17108}}, {'city': 'Kroměříž', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.29785, 'lon': 17.39312}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Helsinki', 'state': 'Finland', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Joensuu', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'city': 'La Roche-sur-Yon', 'state': 'FRANCEnce', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Marseille', 'state': 'FRANCEnce', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'state': 'FRANCEnce', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'state': 'FRANCEnce', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Villejuif', 'state': 'FRANCEnce', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Herblain', 'state': 'Saint Herblain', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hanover', 'state': 'GERMANYmany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Emmendingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.12096, 'lon': 7.85359}}, {'city': 'Kirchheim-Teck', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Budapest', 'state': 'HUNGARYary', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Győr', 'state': 'HUNGARYary', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Miskolc', 'state': 'HUNGARYary', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Ny Regyh Za', 'state': 'HUNGARYary', 'country': 'Hungary', 'facility': 'Research Site'}, {'city': 'Szeged', 'state': 'HUNGARYary', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Trivandrum', 'state': 'Kerala', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'city': 'Bhopal', 'state': 'Madhya Pradesh', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 23.25469, 'lon': 77.40289}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Bikaner', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.01762, 'lon': 73.31495}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Kolkota', 'state': 'West Bengal', 'country': 'India', 'facility': 'Research Site'}, {'city': 'Delhi', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Genoa', 'state': 'Italy', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'city': 'Lugo (RA)', 'state': 'Italy', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.42137, 'lon': 11.91094}}, {'city': 'Rome', 'state': 'Italy', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Cercado de Arequipa', 'state': 'Arequipa', 'country': 'Peru', 'facility': 'Research Site'}, {'city': 'Cercado', 'state': 'Arequipa', 'country': 'Peru', 'facility': 'Research Site'}, {'city': 'Callao', 'country': 'Peru', 'facility': 'Research Site', 'geoPoint': {'lat': -12.05162, 'lon': -77.13452}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Research Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lublin', 'state': 'POLANDand', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Swidnica', 'state': 'POLANDand', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.84378, 'lon': 16.48859}}, {'city': 'Warszaa', 'state': 'POLANDand', 'country': 'Poland', 'facility': 'Research Site'}, {'city': 'Kościerzyna', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.12226, 'lon': 17.98119}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Coimbra', 'state': 'PORTUGALtugal', 'country': 'Portugal', 'facility': 'Research Site', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'PORTUGALto', 'state': 'PORTUGALtugal', 'country': 'Portugal', 'facility': 'Research Site'}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Barnaul', 'state': 'RUSSIAsia', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': 'Izhevsk', 'state': 'RUSSIAsia', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'city': 'Kursk', 'state': 'RUSSIAsia', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'city': 'Sochi', 'state': 'RUSSIAsia', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.59699, 'lon': 39.72477}}, {'city': 'Voronezh', 'state': 'RUSSIAsia', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'city': 'Belgrade', 'state': 'SERBIAbia', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niš', 'state': 'SERBIAbia', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Panorama', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -28.75383, 'lon': 31.89113}}, {'city': 'TyGERberg', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site'}, {'city': 'Overport', 'state': 'Durban', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.8348, 'lon': 31.00012}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Ilsandong-gu, Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Nowon-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Seodaemun-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Songpa-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Madrid', 'state': 'Spain', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valencia', 'state': 'Spain', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Stockholm', 'state': 'Sweden', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Locarno', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 46.17086, 'lon': 8.79953}}, {'city': 'Sursee', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.17088, 'lon': 8.11113}}, {'city': 'Kaohsiung City', 'state': 'TAIWANwan', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'TAIWANpei', 'state': 'TAIWANwan', 'country': 'Taiwan', 'facility': 'Research Site'}, {'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'city': 'Manchester', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Westgate Road', 'state': 'Newcastle Upon Tyne', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Karim Fizazi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'Judd W Moul, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}