Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT00075218
Status:
COMPLETED
Last Update Posted:
2009-09-28
First Post:
2004-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
Sponsor:
Organization:
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.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Duration of Tumor Response could not be reliably estimated at the time of analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.', 'otherNumAffected': 223, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.', 'otherNumAffected': 110, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'Sunitinib Open-Label Treatment', 'description': 'Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.', 'otherNumAffected': 254, 'seriousNumAffected': 122}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 80}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 64}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand and foot syndrome secondary to sickle cell anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left atrial dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 45}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 119}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 114}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 93}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '32.1'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.329', 'ciLowerLimit': '0.233', 'ciUpperLimit': '0.466', 'pValueComment': "The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.", 'groupDescription': 'The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'two-sided unstratified log-rank test', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28 of each 6-week cycle : duration of double-blind treatment phase', 'description': 'Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '28.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '9.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.347', 'ciLowerLimit': '0.253', 'ciUpperLimit': '0.475', 'pValueComment': 'No p-value adjustment for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Survival Status of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'title': 'Dead', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Alive', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'Number of subjects alive at end of study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '83.0'}, {'value': '64.9', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '96.0'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.876', 'ciLowerLimit': '0.679', 'ciUpperLimit': '1.129', 'pValueComment': 'No p-value adjustment for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'Time from date of randomization to date of death due to any cause.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Based on the Rank Preserving Structural Failure Time Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '83.0'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '28.0', 'upperLimit': '54.1'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.505', 'ciLowerLimit': '0.262', 'ciUpperLimit': '1.134', 'pValueComment': 'No p-value adjustment for multiple comparisons.', 'estimateComment': '95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.', 'statisticalMethod': 'Rank Preserving Structural Failure Time', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'time from date of randomization to date of death due to any cause (rank preserving structural failure time method).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Best Overall Tumor Response During Double-blind Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Unable to Evaluate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Confirmed Objective Response (CR or PR) in Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate (percentage)', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '3.8', 'ciUpperLimit': '10.5', 'estimateComment': 'Used exact method based on binomial distribution.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (%)', 'ciPctValue': '95', 'paramValue': '6.58', 'ciLowerLimit': '3.47', 'ciUpperLimit': '9.70', 'pValueComment': 'No p-value adjustment for multiple comparisons.', 'statisticalMethod': 'Pearson chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '16.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of subjects analyzed = number of subjects with tumor response.'}, {'type': 'SECONDARY', 'title': 'Duration of Performance Status Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '31.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.'}, {'type': 'PRIMARY', 'title': 'Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '32.1'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.339', 'ciLowerLimit': '0.244', 'ciUpperLimit': '0.472', 'pValueComment': 'two-sided unstratified log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.327', 'ciLowerLimit': '0.232', 'ciUpperLimit': '0.460', 'groupDescription': 'Stratified log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score", 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)', 'description': 'Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '27.1'}]}]}], 'analyses': [{'pValue': '0.9322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.972', 'ciLowerLimit': '0.508', 'ciUpperLimit': '1.860', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '2-sided, unstratified log-rank test', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': '25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use \\>= 50% over baseline OR b) Increase score \\>= 1 point with either NC in total analgesic use or increase total analgesic use \\>= 50% over baseline. (50th Quartile not achieved.)', 'unitOfMeasure': 'weeks (25th Quartile)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.'}, {'type': 'SECONDARY', 'title': 'Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (percent)', 'ciPctValue': '95', 'paramValue': '17.3', 'ciLowerLimit': '6.7', 'ciUpperLimit': '28.0', 'estimateComment': '95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\\*100.', 'statisticalMethod': 'Pearson chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \\>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \\>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \\>= 50% over baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pain-Relief-Response population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'title': 'Cycle 1 Day 28 (n=187, 89)', 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-60.0', 'upperLimit': '70.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '45.0'}]}]}, {'title': 'Cycle 2 Day 1 (n=148, 53)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-60.0', 'upperLimit': '55.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-30.0', 'upperLimit': '41.0'}]}]}, {'title': 'Cycle 2 Day 28 (n=132, 41)', 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-50.0', 'upperLimit': '55.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-80.0', 'upperLimit': '40.0'}]}]}, {'title': 'Cycle 3 Day 1 (n=102,16)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-58.0', 'upperLimit': '32.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-75.0', 'upperLimit': '34.0'}]}]}, {'title': 'Cycle 3 Day 28 (n=91,13)', 'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-55.0', 'upperLimit': '42.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-75.0', 'upperLimit': '16.0'}]}]}, {'title': 'Cycle 4 Day 1 (n=73,10)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-65.0', 'upperLimit': '40.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient\'s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D Health State Profile Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'OG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}], 'classes': [{'title': 'Cycle 1 Day 28 (n=185, 87)', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-1.008', 'upperLimit': '0.736'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.655', 'upperLimit': '0.532'}]}]}, {'title': 'Cycle 2 Day 1 (n=149, 53)', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-1.244', 'upperLimit': '0.603'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.603', 'upperLimit': '0.434'}]}]}, {'title': 'Cycle 2 Day 28 (n=129, 41)', 'categories': [{'measurements': [{'value': '-0.017', 'groupId': 'OG000', 'lowerLimit': '-1.008', 'upperLimit': '0.603'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.694', 'upperLimit': '0.655'}]}]}, {'title': 'Cycle 3 Day 1 (n=104, 17)', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.694', 'upperLimit': '0.639'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.655', 'upperLimit': '0.192'}]}]}, {'title': 'Cycle 3 Day 28 (n=91, 13)', 'categories': [{'measurements': [{'value': '-0.036', 'groupId': 'OG000', 'lowerLimit': '-1.175', 'upperLimit': '0.736'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.655', 'upperLimit': '0.204'}]}]}, {'title': 'Cycle 4 Day 1 (n=74, 10)', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.768', 'upperLimit': '0.603'}, {'value': '0.059', 'groupId': 'OG001', 'lowerLimit': '-0.152', 'upperLimit': '0.275'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'FG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}, {'id': 'FG002', 'title': 'Sunitinib Open-Label Treatment', 'description': 'Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.'}], 'periods': [{'title': 'Double-Blind Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intent To Treat Population (ITT)', 'groupId': 'FG000', 'numSubjects': '243'}, {'comment': 'Intent To Treat Population (ITT)', 'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received Double-Blind Treatment', 'achievements': [{'comment': 'As Treated Population (AT)', 'groupId': 'FG000', 'numSubjects': '228'}, {'comment': 'As Treated Population (AT)', 'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Crossed Over to Open-Label Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Defined:subjects completed double-blind treatment phase and/or entered open-label treatment phase.', 'groupId': 'FG000', 'numSubjects': '152'}, {'comment': 'Defined:subjects completed double-blind treatment phase and/or entered open-label treatment phase.', 'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Decision of Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No study medication taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '255'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '174'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Decision of Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'enrolled in a separate continuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Enrollment began (medical clinic) in December 2003. Study was unblinded on 27 January 2005 (end of Double-blind treatment). Subjects experiencing disease progression could crossover to Open-label treatment. Open-label data collection ended May 2008.', 'preAssignmentDetails': '361 subjects randomized to double-blind treatment in 2:1 ratio (sunitinib vs. Placebo).\n\n255 subjects continued on or crossed over to Open-label treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sunitinib Double-Blind Treatment', 'description': 'Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.'}, {'id': 'BG001', 'title': 'Placebo Double-Blind Treatment', 'description': 'Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '251.0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '110.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '162.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '199.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-31', 'studyFirstSubmitDate': '2004-01-06', 'resultsFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2004-01-07', 'lastUpdatePostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-31', 'studyFirstPostDateStruct': {'date': '2004-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase', 'timeFrame': 'Day 28 of each 6-week cycle : duration of double-blind treatment phase', 'description': 'Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).'}, {'measure': 'Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study', 'timeFrame': 'Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)', 'description': 'Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).'}, {'measure': 'Overall Survival Status of Subjects', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'Number of subjects alive at end of study.'}, {'measure': 'Overall Survival', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'Time from date of randomization to date of death due to any cause.'}, {'measure': 'Overall Survival Based on the Rank Preserving Structural Failure Time Method', 'timeFrame': 'clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug', 'description': 'time from date of randomization to date of death due to any cause (rank preserving structural failure time method).'}, {'measure': 'Best Overall Tumor Response During Double-blind Treatment Phase', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).'}, {'measure': 'Confirmed Objective Response (CR or PR) in Subjects', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.'}, {'measure': 'Time to Tumor Response (TTR)', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.'}, {'measure': 'Duration of Performance Status Maintenance', 'timeFrame': 'Day 28 of each cycle : duration of double-blind treatment phase', 'description': 'Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.'}, {'measure': 'Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': '25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use \\>= 50% over baseline OR b) Increase score \\>= 1 point with either NC in total analgesic use or increase total analgesic use \\>= 50% over baseline. (50th Quartile not achieved.)'}, {'measure': 'Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \\>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \\>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \\>= 50% over baseline.'}, {'measure': 'Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient\'s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.'}, {'measure': 'Change From Baseline in EQ-5D Health State Profile Index', 'timeFrame': 'Day 1 & 28 of each cycle : duration of double-blind treatment phase', 'description': 'Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastrointestinal Stromal Tumor']}, 'referencesModule': {'references': [{'pmid': '17046465', 'type': 'DERIVED', 'citation': 'Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181004&StudyName=A%20Study%20To%20Assess%20The%20Safety%20And%20Efficacy%20Of%20SU11248%20In%20Patients%20With%20Gastrointestinal%20Stromal%20Tumors%20%28GIST%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent\n* Failed Gleevec treatment or intolerant to Gleevec therapy\n\nKey Exclusion Criteria:\n\n* Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec'}, 'identificationModule': {'nctId': 'NCT00075218', 'briefTitle': 'A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)', 'nctIdAliases': ['NCT00085618'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor', 'orgStudyIdInfo': {'id': 'A6181004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: SU011248']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.', 'armGroupLabels': ['B']}, {'name': 'SU011248', 'type': 'DRUG', 'description': '50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095-6984', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 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