Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01271712
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2010-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, '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': 'C559147', 'term': 'regorafenib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Overall survival results are confounded by the fact that 85% of the participants initially randomized to placebo switched to open-label regorafenib.'}}, 'adverseEventsModule': {'timeFrame': 'From first administration of treatment till 30 days after last dose of treatment.', 'description': 'At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\\>1 year".', 'eventGroups': [{'id': 'EG000', 'title': 'Regorafenib (Double Blind Only)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 40, 'seriousNumAtRisk': 41, 'deathsNumAffected': 40, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Placebo (Double Blind Only)', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 7, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Placebo, Open Label Only (Switch to Regorafenib)', 'description': 'Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 58, 'seriousNumAtRisk': 58, 'deathsNumAffected': 47, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Treated With Regorafenib at Any Time', 'description': 'Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 189, 'seriousNumAtRisk': 190, 'deathsNumAffected': 155, 'seriousNumAffected': 103}, {'id': 'EG004', 'title': 'Treated With Regorafenib for > 1 Year', 'description': 'Treated with Regorafenib for \\> 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 75, 'seriousNumAtRisk': 75, 'deathsNumAffected': 48, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ear and labyrinth disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 25, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 77, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 35, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 50, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 32, 'numAffected': 25}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 122, 'numAffected': 62}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 60, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 101, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 52, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 67, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 353, 'numAffected': 96}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 281, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 39, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 30, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 48, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 174, 'numAffected': 81}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 111, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 33, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 110, 'numAffected': 61}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 66, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 24, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 85, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 54, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 72, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 53, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 32, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 83, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 251, 'numAffected': 104}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 137, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 83, 'numAffected': 52}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 46, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'General disorders and administration site conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 46, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 115, 'numAffected': 55}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 73, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 41, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 58, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 24, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 52, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 27, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 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'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Eye disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Psychiatric disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Renal and urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Surgical and medical procedures - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vascular disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000', 'lowerLimit': '122', 'upperLimit': '173'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '32'}]}]}], 'analyses': [{'pValue': '<0.000001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.268', 'ciLowerLimit': '0.185', 'ciUpperLimit': '0.388', 'estimateComment': 'regorafenib over placebo', 'groupDescription': 'Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)', 'description': 'Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000'}, {'value': '80.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.285777', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.909', 'ciLowerLimit': '0.653', 'ciUpperLimit': '1.265', 'estimateComment': 'regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.', 'groupDescription': 'Hazard ratio and its 95% CI was based on stratified Cox Regression Model', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization of the first subject until date of database cutoff (08 Jun 2015)', 'description': 'Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.', 'unitOfMeasure': 'Percentage of patients with death', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '125', 'upperLimit': '174'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '34'}]}]}], 'analyses': [{'pValue': '<0.000001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.248', 'ciLowerLimit': '0.170', 'ciUpperLimit': '0.364', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST \\[Response Evaluation Criteria in Solid Tumors\\] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '9.6'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.2'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '63.0', 'upperLimit': '78.9'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '46.0'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '29.0'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '50.9', 'upperLimit': '75.1'}]}]}, {'title': 'Not Assessable', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '7.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Tumor Response of a subject was defined as the best tumor response (Complete Response \\[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\\], Partial Response \\[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\], Stable Disease \\[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\], or Progressive Disease \\[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '9.6'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.', 'description': 'Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '61.3'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '18.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'comment': 'A complete confidence interval (CI) cannot be calculated because there are too few patients in the data set.', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': 'NA'}, {'value': '30', 'comment': 'CI cannot be calculated because there is only 1 patient in the data set.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Duration of Response was defined as the time from date of first response (Complete Response \\[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\\] or Partial Response \\[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with response participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'FG001', 'title': 'Placebo First, Then Option of Open Label Regorafenib Treatment', 'description': 'Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.'}], 'periods': [{'title': 'Double Blind Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '91 participants started open-label treatment with regorafenib', 'groupId': 'FG000', 'numSubjects': '91'}, {'comment': '58 participants started open-label treatment with regorafenib', 'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'receive no study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open Label Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'transferred to rollover study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Switching to other therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants who discontinued study drug entered 30-day Safety Follow-up', 'groupId': 'FG000', 'numSubjects': '118'}, {'comment': 'All participants who discontinued study drug entered 30-day Safety Follow-up', 'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not analyzed after cutoff 08Jun2015', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'No follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Survival Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants entered Survival Follow-up immediately after safety follow-up', 'groupId': 'FG000', 'numSubjects': '100'}, {'comment': 'All participants entered Survival Follow-up immediately after safety follow-up', 'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '85 participants died and completed survival follow-up.', 'groupId': 'FG000', 'numSubjects': '85'}, {'comment': '33 participants died and completed survival follow-up.', 'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Not analyzed after cutoff 08Jun2015', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 240 participants with metastatic and/or unresectable GIST whose disease had progressed despite prior treatments with at least imatinib and sunitinib were screened; 199 were randomized. Patients must have shown objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib treatment.', 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio to receive either regorafenib (133 patients) or placebo (66 patients). Randomization was stratified according 3rd vs. 4th line of therapy (at least 50% of patients were to be 3rd line), and geographical region (Asia vs.rest of world).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status (PS)]', 'classes': [{'categories': [{'title': 'PS 0', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'PS 1', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'PS 2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).', 'unitOfMeasure': 'Participants'}, {'title': 'Prior anti-cancer drug group', 'classes': [{'categories': [{'title': '3rd line', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': '4th line and beyond', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '3rd line: 3rd in sequence of multiple therapies: imatinib (1st); sunitinib (2nd). 4th line and beyond: 4th in sequence of multiple therapies: imatinib (1st); sunitinib (2nd); other (3rd).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2013-01-30', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2010-12-17', 'dispFirstSubmitQcDate': '2013-01-30', 'resultsFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2011-01-06', 'dispFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-21', 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)', 'description': 'Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization of the first subject until date of database cutoff (08 Jun 2015)', 'description': 'Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST \\[Response Evaluation Criteria in Solid Tumors\\] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.'}, {'measure': 'Tumor Response', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Tumor Response of a subject was defined as the best tumor response (Complete Response \\[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\\], Partial Response \\[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\], Stable Disease \\[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\], or Progressive Disease \\[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.', 'description': 'Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year', 'description': 'Duration of Response was defined as the time from date of first response (Complete Response \\[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\\] or Partial Response \\[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\\]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal stromal cancer', 'GIST', 'multikinase inhibitor'], 'conditions': ['Gastrointestinal Stromal Tumors']}, 'referencesModule': {'references': [{'pmid': '23177515', 'type': 'RESULT', 'citation': 'Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schoffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG; GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302. doi: 10.1016/S0140-6736(12)61857-1. Epub 2012 Nov 22.'}, {'pmid': '24957256', 'type': 'RESULT', 'citation': 'Poole CD, Connolly MP, Chang J, Currie CJ. Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo. Gastric Cancer. 2015 Jul;18(3):627-34. doi: 10.1007/s10120-014-0391-x. Epub 2014 Jun 24.'}, {'pmid': '25655899', 'type': 'RESULT', 'citation': 'Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.'}, {'pmid': '22421192', 'type': 'DERIVED', 'citation': 'Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer Healthcare products.'}, {'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.\n\nThe study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.\n\nSubjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.\n\nTumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review.\n\nSubjects receiving placebo who experience disease progression may be offered active treatment.\n\nSubjects who experience progression during regorafenib treatment may continue open label treatment.\n\nAll subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 18 years of age.\n* Subjects with histologically confirmed metastatic and/or unresectable GIST.\n* At least imatinib and sunitinib as prior treatment regimens, with objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib therapy. Additionally, disease progression or intolerance to other systemic therapies, as well as investigational new agents, is allowed, except prior treatment with any other vascular endothelial growth factor receptor (VEGFR) inhibitor.\n* Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment.\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\n* Adequate bone marrow, liver, and renal function as assessed by laboratory parameters.\n\nRecovery to NCI-CTCAE v4.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure-related toxicity (except alopecia and anemia).\n\nExclusion Criteria:\n\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.\n* Congestive heart failure New York Heart Association (NYHA) class 2.\n* Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.\n* Uncontrolled hypertension (systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management).\n\nArterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before start of study drug or venous thrombotic events such as deep vein thrombosis within the 3 months before start of study drug.\n\n* Ongoing infection grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.\n\nSymptomatic metastatic brain or meningeal tumors.\n\n* Subjects with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event NCI-CTCAE version 4.0 grade 3 or higher within 4 weeks prior to the start of study drug.\n\nNon-healing wound, ulcer, or bone fracture.\n\n* Persistent proteinuria of NCI-CTCAE version 4.0 grade 3 or higher (3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample).'}, 'identificationModule': {'nctId': 'NCT01271712', 'acronym': 'GRID', 'briefTitle': 'Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care for Subjects With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) Whose Disease Has Progressed Despite Prior Treatment With at Least Imatinib and Sunitinib', 'orgStudyIdInfo': {'id': '14874'}, 'secondaryIdInfos': [{'id': '2009-017957-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regorafenib (Stivarga, BAY73-4506)', 'description': 'Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'interventionNames': ['Drug: Regorafenib (Stivarga, BAY73-4506)', 'Drug: Best supportive care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks', 'interventionNames': ['Drug: Placebo', 'Drug: Best supportive care']}], 'interventions': [{'name': 'Regorafenib (Stivarga, BAY73-4506)', 'type': 'DRUG', 'description': '160 mg po once daily (od), 3 weeks on/1 week off. Route of administration: oral', 'armGroupLabels': ['Regorafenib (Stivarga, BAY73-4506)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily (od), 3 weeks on/1 week off. Route of administration: oral', 'armGroupLabels': ['Placebo']}, {'name': 'Best supportive care', 'type': 'DRUG', 'description': 'Best supportive care includes any method to preserve the comfort and dignity of the patients, and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgical intervention.', 'armGroupLabels': ['Placebo', 'Regorafenib (Stivarga, BAY73-4506)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': 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