Viewing Study NCT00444795

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Ignite Creation Date: 2025-12-24 @ 1:47 PM
Ignite Modification Date: 2025-12-24 @ 1:47 PM
Study NCT ID: NCT00444795
Status: COMPLETED
Last Update Posted: 2017-02-01
First Post: 2007-03-07
Is Possible Gene Therapy: False
Has Adverse Events: True
Brief Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@Pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.', 'description': 'The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sutene', 'description': 'Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 617, 'otherNumAffected': 474, 'seriousNumAtRisk': 617, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 159}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 109}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Oedema periorbital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Palmar-plantar erythrodysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 191}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 59}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 50}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 44}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 95}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 137}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Mucositis nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 115}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 145}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 72}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Serum glutamic-oxaloacetic transaminase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 44}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Serum glutamate pyruvate transaminase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 32}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 137}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 80}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 35}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 113}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}], 'seriousEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Circulatory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Convulsions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Abdomen enlarged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haemorrhage rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hiccup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Intestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Bilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hepatorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Carcinoma of oesophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Gastric carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pulmonary carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Purpura thrombopenic thrombotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Mental deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haemolytic-uraemic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Shock septic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Post-operative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Surgical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Haemorrhage nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Thrombophlebitis deep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 617, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART version 092'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sutene', 'description': 'Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '80.23', 'groupId': 'OG000', 'lowerLimit': '77.08', 'upperLimit': '83.37'}]}]}, {'title': 'ADRs', 'categories': [{'measurements': [{'value': '76.50', 'groupId': 'OG000', 'lowerLimit': '73.15', 'upperLimit': '79.85'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '11.67', 'groupId': 'OG000', 'lowerLimit': '9.14', 'upperLimit': '14.20'}]}]}, {'title': 'SADRs', 'categories': [{'measurements': [{'value': '7.46', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '9.53'}]}]}, {'title': 'Unexpected AEs', 'categories': [{'measurements': [{'value': '44.57', 'groupId': 'OG000', 'lowerLimit': '40.65', 'upperLimit': '48.49'}]}]}, {'title': 'Unexpected ADRs', 'categories': [{'measurements': [{'value': '35.17', 'groupId': 'OG000', 'lowerLimit': '31.40', 'upperLimit': '38.94'}]}]}, {'title': 'Unexpected SAEs', 'categories': [{'measurements': [{'value': '6.32', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '8.24'}]}]}, {'title': 'Unexpected SADRs', 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '1.47', 'upperLimit': '4.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. 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Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sutene', 'description': 'Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.48', 'groupId': 'OG000', 'lowerLimit': '73.87', 'upperLimit': '81.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of study treatment, average of 23.2 weeks.', 'description': 'The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Analysis Set: Participants who administered Sutene at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sutene', 'description': 'Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '620'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Refer to the Safety Analysis Set.', 'groupId': 'FG000', 'numSubjects': '617'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Treated Prior to the Contract Date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This post marketing surveillance (PMS) study enrolled 520 participants between December 2007 and March 2015. Data from 100 participants were obtained from a previously completed study (A6181037).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sutene', 'description': 'Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.94', 'spread': '11.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '468', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Advanced Renal Cell Carcinoma', 'categories': [{'measurements': [{'value': '550', 'groupId': 'BG000'}]}]}, {'title': 'Gastrointestinal Stromal Tumor', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Progressive Pancreatic Neuroendocrine Carcinoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: Participants who administered Sutene at least once and were evaluated upon its related safety endpoints at least once.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2007-03-07', 'resultsFirstSubmitDate': '2016-02-19', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-23', 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs', 'timeFrame': 'From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no" (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'At the end of study treatment, average of 23.2 weeks.', 'description': 'The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. 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PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SUTENE', 'post-marketing surveillance', 'GIST', 'RCC', 'Korea'], 'conditions': ['Gastrointestinal Stromal Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181146&StudyName=Post%20Marketing%20Surveillance%20Study%20To%20Observe%20Safety%20And%20Efficacy%20Of%20Sutene', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)', 'detailedDescription': 'All the patients prescribed according to approved indications at contracted institutions'}, 'eligibilityModule': {'sex': 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