Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02371369
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2015-02-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013586', 'term': 'Synovitis, Pigmented Villonodular'}, {'id': 'D000070779', 'term': 'Giant Cell Tumor of Tendon Sheath'}], 'ancestors': [{'id': 'D005870', 'term': 'Giant Cell Tumors'}, {'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': 'D013585', 'term': 'Synovitis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600259', 'term': 'pexidartinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '1-908-992-6400', 'title': 'Daiichi Sankyo', 'organization': 'Contact for Clinical Trial Information'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Enrollment was stopped on 30 Sep 2016; no new participants received the study drug. After Part 1, those who wished to continue were un-blinded; those on placebo were discontinued.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Pexidartinib (Part 1)', 'description': 'Participants received blinded treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 60, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo (Part 1)', 'description': 'Participants received blinded treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks\n\nPlacebo: Placebo capsule matching pexidartinib capsule for oral administration', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 55, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Pexidartinib (Parts 1 and 2)', 'description': 'Participants received pexidartinib in Part 1 and in Part 2 at their prescribed dose\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 61, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Placebo (Part 1), Crossover Pexidartinib (Part 2)', 'description': 'Participants received placebo in Part 1 and pexidartinib in Part 2 at their prescribed dose\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration\n\nPlacebo: Placebo capsule matching pexidartinib capsule for oral administration', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received pexidartinib in Part 1 and Part 2 (placebo crossed over to pexidartinib)', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 91, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 45, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 49, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 57, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 70, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 24, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 34, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 48, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 63, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 74, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 44, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 53, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 66, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 26, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 30, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 31, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 23, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Blood creatinine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 27, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 43, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 17, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 33, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Response (CR or PR)', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment comparison between the pexidartinib and placebo groups at Week 25', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment comparison analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 25', 'description': 'Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall response was assessed in the Intent-to-Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '62.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0043', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment comparison between the pexidartinib and placebo groups at Week 25', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment comparison analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 13, and Week 25', 'description': 'Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Range of motion was assessed in the ITT population in participants where data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Response (CR or PR)', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment comparison between the pexidartinib and placebo groups at Week 25', 'statisticalMethod': "Fisher's Exact Test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment comparison analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 25', 'description': 'Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall response was assessed in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment comparison between pexidartinib and placebo groups at Week 25', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment comparison analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 9 , Week 17, and Week 25', 'description': "The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Physical function was assessed in the ITT population in participants where data were available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment comparison between the pexidartinib and placebo groups at Week 25', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment comparison analysis'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 9, Week 17, and Week 25', 'description': 'The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Worst stiffness was assessed in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 25', 'description': 'The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Worst pain was assessed in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Responders to Pexidartinib With and Without Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks\n\nPart 2: Participants also received pexidartinib at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Number of responses', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (Day 84); Without disease progression', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (Day 84); With disease progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (Day 168); Without disease progression', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (Day 168); With disease progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (Day 336); Without disease progression', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (Day 336); With disease progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 72 (Day 504); Without disease progression', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Week 72 (Day 504); With disease progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 96 (Day 672); Without disease progression', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 96 (Day 672); With disease progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By Week 96', 'description': 'Duration of response (DOR) based on RECIST 1.1 is defined as the date of the first recorded response to the first date of documented disease progression. The overall number of responses and the number of participants with and without disease progression was assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of responses and the number of participants with and without disease progression were assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only, All Pexidartinib Treated participants, . Participants randomized to Placebo Part 1 only were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Responders to Pexidartinib With and Without Disease Progression Based on Tumor Volume Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib in Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received pexidartinib in Part 1 and Part 2 as well as those who received pexidartinib in Part 2 only.'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (Day 84); Without disease progression', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (Day 84); With disease progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (Day 168); Without disease progression', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (Day 168); With disease progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (Day 336); Without disease progression', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (Day 336); With disease progression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 72 (Day 504); Without disease progression', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Week 72 (Day 504); With disease progression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96 (Day 672); Without disease progression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96 (Day 672); With disease progression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 120 (Day 840); Without disease progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 120 (Day 840); With disease progression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By Week 120', 'description': 'Tumor Volume Score (TVS) is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. The overall number of responses and the number of participants with and without disease progression was assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of responses and the number of participants with and without disease progression was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '31.01', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '39.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)', 'description': 'Duration of response (DOR) based on RECIST 1.1 is defined from the date of the first recorded evidence of response to the first date of documented disease progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on Tumor Volume Score (TVS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '52.70', 'comment': 'Upper limit 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '38.60', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CIs was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)', 'description': 'Duration of response (DOR) based on TVS is defined from the date of the first recorded evidence of response to the first date of documented disease progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.'}, {'id': 'OG002', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG003', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG004', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Any Hair color changes', 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '73.8', 'groupId': 'OG002'}, {'value': '83.3', 'groupId': 'OG003'}, {'value': '76.9', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Hair color changes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Pruritis', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '17.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Pruritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Rash maculopapular', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '14.8', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '13.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Rash maculopapular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Pruritis generalized', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Pruritis generalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Dry skin', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '7.7', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Dry skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Photosensitivity reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '4.4', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Photosensitivity reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Nausea', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '36.3', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Diarrhea', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '26.2', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '27.5', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '23.0', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '17.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Vomiting', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Abdominal Pain', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '21.3', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '16.5', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Abdominal Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Dry mouth', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '13.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Dry mouth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Constipation', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '14.8', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '13.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Constipation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Stomatitis', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Stomatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}, {'value': '55.7', 'groupId': 'OG002'}, {'value': '26.7', 'groupId': 'OG003'}, {'value': '46.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Edema peripheral', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '17.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Edema peripheral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Face edema', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '14.8', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '16.5', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Face edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '2.2', 'groupId': 'OG004'}]}]}, {'title': 'Any Asthenia', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Asthenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Pyrexia', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '9.9', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥ Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any AST increased', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '35.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 AST increased', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Any ALT increased', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '31.1', 'groupId': 'OG002'}, {'value': '23.3', 'groupId': 'OG003'}, {'value': '28.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 ALT increased', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '9.9', 'groupId': 'OG004'}]}]}, {'title': 'Any ALP increased', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14.8', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '11.0', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 ALP increased', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '5.5', 'groupId': 'OG004'}]}]}, {'title': 'Any LDH increased', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '11.0', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 LDH increased', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Weight increased', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '6.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Weight increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Dysgeusia', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '27.9', 'groupId': 'OG002'}, {'value': '23.3', 'groupId': 'OG003'}, {'value': '26.4', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Dysgeusia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}, {'value': '23.0', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '22.0', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Dizziness', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '13.2', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Dizziness', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Paresthesia', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Paresthesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Memory impairment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '4.4', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Memory impairment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '27.9', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '28.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Arthralgia', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2.2', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain in extremity', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '11.0', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Pain in extremity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Periorbital edema', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Periorbital edema', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Any Eyelid edema', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '6.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Eyelid edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Decreased appetite', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '18.0', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '15.4', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Decreased appetite', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Hypertension', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '19.7', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '13.1', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Hypertension', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '5.5', 'groupId': 'OG004'}]}]}, {'title': 'Any Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Cough', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '7.7', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Dyspnea', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '7.7', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Dyspnea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Insomnia', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '6.6', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Insomnia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Rash', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '27.9', 'groupId': 'OG002'}, {'value': '23.3', 'groupId': 'OG003'}, {'value': '26.4', 'groupId': 'OG004'}]}]}, {'title': 'Grade ≥3 Rash', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first dose of treatment up to 28 days after the last dose', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the first dose of treatment and within 28 days after the last dose. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 was used to grade adverse events. Any Grade and Grade ≥3 (severe) TEAEs are reported. TEAEs were coded using MedDRA version 17.1.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety events were assessed in the Safety Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}]}]}, {'title': 'Response (CR or PR)', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By Week 49', 'description': 'Complete (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall response was assessed in the ITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.5', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '63.8', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '17.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'By Week 49', 'description': 'Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Range of Motion (ROM) was assessed in the ITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'By Week 49', 'description': "The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Physical function was assessed in the ITT population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25, and Week 49', 'description': 'The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Worst stiffness was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'By Week 49', 'description': 'The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pexidartinib Part 1 and Part 2', 'description': 'Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG001', 'title': 'Placebo Part 1, Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.'}, {'id': 'OG002', 'title': 'All Pexidartinib Treated', 'description': 'All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '64.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By Week 49', 'description': 'Best overall response (CR or PR) was assessed using tumor volume score (TVS) in the ITT population. Tumor Volume Score is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall response on Tumor Volume Score was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed..'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pexidartinib Part 1, Then Pexidartinib Part 2', 'description': 'Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration.'}, {'id': 'FG001', 'title': 'Placebo Part 1, Then Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching Pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration (Part 2).'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'N=48; Only participants who were eligible to receive treatment in Part 2.', 'groupId': 'FG000', 'numSubjects': '48'}, {'comment': 'N=30; Only participants who were eligible to receive treatment in Part 2.', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject transitioned to commercial supply', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Subject transitioned to another DS pexidartinib protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Surgical resection of tumor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Part 1 was a double-blind, randomized, Pexidartinib or placebo in participants with symptomatic TGCT for whom surgical resection would be associated with potentially worsening functional limitation or severe morbidity. Part 2 is a long-term treatment phase in which all eligible participants received open-label Pexidartinib.', 'preAssignmentDetails': 'Participants were screened for inclusion and exclusion criteria. Screening procedures were performed after consent was obtained and within the 42 days before the first dose of study drug, unless otherwise noted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pexidartinib Part 1, Then Pexidartinib Part 2', 'description': 'Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.\n\nPexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration'}, {'id': 'BG001', 'title': 'Placebo Part 1, Then Pexidartinib Part 2', 'description': 'Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.\n\nPlacebo: Placebo capsule matching pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration (Part 2).'}, {'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', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '44.5', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-22', 'size': 2396245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-30T08:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) in Part 1, Open-label (no masking) in Part 2'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2015-02-19', 'resultsFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 by Week 49', 'timeFrame': 'By Week 49', 'description': 'Complete (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.'}, {'measure': 'Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'timeFrame': 'By Week 49', 'description': 'Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.'}, {'measure': 'Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'timeFrame': 'By Week 49', 'description': "The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes."}, {'measure': 'Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'timeFrame': 'Baseline, Week 25, and Week 49', 'description': 'The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).'}, {'measure': 'Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'timeFrame': 'By Week 49', 'description': 'The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo by Week 49', 'timeFrame': 'By Week 49', 'description': 'Best overall response (CR or PR) was assessed using tumor volume score (TVS) in the ITT population. Tumor Volume Score is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25', 'timeFrame': 'Week 25', 'description': 'Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'timeFrame': 'Baseline, Week 13, and Week 25', 'description': 'Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.'}, {'measure': 'Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25', 'timeFrame': 'Week 25', 'description': 'Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.'}, {'measure': 'Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'timeFrame': 'at Week 9 , Week 17, and Week 25', 'description': "The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes."}, {'measure': 'Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25', 'timeFrame': 'Baseline, Week 9, Week 17, and Week 25', 'description': 'The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).'}, {'measure': 'Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25', 'timeFrame': 'Week 25', 'description': 'The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Number of Responders to Pexidartinib With and Without Disease Progression', 'timeFrame': 'By Week 96', 'description': 'Duration of response (DOR) based on RECIST 1.1 is defined as the date of the first recorded response to the first date of documented disease progression. The overall number of responses and the number of participants with and without disease progression was assessed.'}, {'measure': 'Number of Responders to Pexidartinib With and Without Disease Progression Based on Tumor Volume Score', 'timeFrame': 'By Week 120', 'description': 'Tumor Volume Score (TVS) is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. The overall number of responses and the number of participants with and without disease progression was assessed.'}, {'measure': 'Duration of Response (DOR) Based on RECIST 1.1', 'timeFrame': 'Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)', 'description': 'Duration of response (DOR) based on RECIST 1.1 is defined from the date of the first recorded evidence of response to the first date of documented disease progression.'}, {'measure': 'Duration of Response (DOR) Based on Tumor Volume Score (TVS)', 'timeFrame': 'Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)', 'description': 'Duration of response (DOR) based on TVS is defined from the date of the first recorded evidence of response to the first date of documented disease progression.'}, {'measure': 'Percentage of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term', 'timeFrame': 'After the first dose of treatment up to 28 days after the last dose', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the first dose of treatment and within 28 days after the last dose. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 was used to grade adverse events. Any Grade and Grade ≥3 (severe) TEAEs are reported. TEAEs were coded using MedDRA version 17.1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PLX3397', 'Pexidartinib', 'Colony Stimulating Factor 1 Receptor (CSF-1R) inhibitor'], 'conditions': ['Pigmented Villonodular Synovitis', 'Giant Cell Tumors of the Tendon Sheath', 'Tenosynovial Giant Cell Tumor']}, 'referencesModule': {'references': [{'pmid': '36001000', 'type': 'DERIVED', 'citation': 'Healey JH, Tap WD, Gelhorn HL, Ye X, Speck RM, Palmerini E, Stacchiotti S, Desai J, Wagner AJ, Alcindor T, Ganjoo K, Martin-Broto J, Wang Q, Shuster D, Gelderblom H, van de Sande M. Pexidartinib Provides Modest Pain Relief in Patients With Tenosynovial Giant Cell Tumor: Results From ENLIVEN. Clin Orthop Relat Res. 2023 Jan 1;481(1):107-116. doi: 10.1097/CORR.0000000000002335. Epub 2022 Aug 24.'}, {'pmid': '33289960', 'type': 'DERIVED', 'citation': 'Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.'}, {'pmid': '32755241', 'type': 'DERIVED', 'citation': 'Tap W. ENLIVEN study: Pexidartinib for tenosynovial giant cell tumor (TGCT). Future Oncol. 2020 Sep;16(25):1875-1878. doi: 10.2217/fon-2020-0307. Epub 2020 Aug 5.'}, {'pmid': '31229240', 'type': 'DERIVED', 'citation': 'Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martin-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. doi: 10.1016/S0140-6736(19)30764-0. Epub 2019 Jun 19.'}, {'pmid': '27041409', 'type': 'DERIVED', 'citation': 'Gelhorn HL, Tong S, McQuarrie K, Vernon C, Hanlon J, Maclaine G, Lenderking W, Ye X, Speck RM, Lackman RD, Bukata SV, Healey JH, Keedy VL, Anthony SP, Wagner AJ, Von Hoff DD, Singh AS, Becerra CR, Hsu HH, Lin PS, Tap WD. Patient-reported Symptoms of Tenosynovial Giant Cell Tumors. Clin Ther. 2016 Apr;38(4):778-93. doi: 10.1016/j.clinthera.2016.03.008. Epub 2016 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good.\n\nThe main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS).\n\nThe study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2.\n\nThen a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. A diagnosis of PVNS or GCT-TS (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi-disciplinary tumor board).\n3. Measurable disease of at least 2 cm and otherwise based on RECIST 1.1, assessed from MRI scans by a central radiologist.\n4. Symptomatic disease because of active PVNS or GCT-TS, defined as one or more of the following:\n\n 1. a worst pain of at least 4 at any time during the week preceding the Screening Visit (based on scale of 0 to 10, with 10 representing "pain as bad as you can imagine").\n 2. a worst stiffness of at least 4 at any time during the week preceding the Screening Visit (based on a scale of 0 to 10, with 10 representing "stiffness as bad as you can imagine").\n5. Stable prescription of analgesic regimen during the 2 weeks prior to randomization.\n6. During the 2 weeks prior to randomization, at least 4 of 7 consecutive days of Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) items and Worst Stiffness NRS items completed correctly.\n7. Women of childbearing potential must have a negative serum pregnancy test within the 14-day period prior to randomization. (Where demanded by local regulations, this test may be required within 72 hours of randomization.)\n8. Males and females of childbearing potential are permitted in the study so long as they consent to avoid getting their partner pregnant or becoming pregnant, respectively, by using a highly effective contraception method, as described below, throughout the study and for up to 90 days after completion. Highly effective methods of contraception include: intra-uterine device (non-hormonal or hormonal), bilateral tubal occlusion, vasectomy, sexual abstinence, or barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year. Women who have documentation of at least 12 months of spontaneous amenorrhea and have a follicle stimulating hormone (FSH) level \\> 40 milli-International units (mIU/mL) will be considered postmenopausal.\n9. Adequate hematologic, hepatic, and renal function, defined by:\n\n * Absolute neutrophil count ≥ 1.5 × 10\\^9/L\n * aspartate aminotransferase/alanine (AST/ALT) ≤ 1.5 × upper limit of normal (ULN)\n * Hemoglobin \\> 10 g/dL\n * Total bilirubin ≤ 1.5 × ULN\n * Platelet count ≥ 100 × 10\\^9/L\n * Serum creatinine ≤ 1.5 × ULN\n10. Willingness and ability to complete the Worst Pain NRS item, Worst Stiffness NRS item, Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Scale, and other self-assessment instruments throughout the study.\n11. Willingness and ability to use an electronic diary.\n12. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.\n\nExclusion Criteria\n\n1. Investigational drug use within 28 days of randomization.\n2. Previous use of pexidartinib or any biologic treatment targeting CSF-1 or the CSF-1R; previous use of oral tyrosine kinase inhibitors, eg, imatinib or nilotinib, are allowed.\n3. Active cancer (either concurrent or within the last year of starting study treatment) that requires therapy (eg, surgical, chemotherapy, or radiation therapy), with the exception of adequately treated basal or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix or breast, or prostate carcinoma with a prostate-specific antigen value \\<0.2 ng/mL.\n4. Known metastatic PVNS/GCT-TS.\n5. Active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus or known active or chronic infection with human immunodeficiency virus.\n6. Known active tuberculosis.\n7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator\'s opinion, would likely interfere with the person\'s study participation or the interpretation of his or her results.\n8. Women who are breastfeeding.\n9. A screening Fridericia corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women).\n10. MRI contraindications.\n11. History of hypersensitivity to any excipients in the investigational product.\n12. Inability to swallow capsules.'}, 'identificationModule': {'nctId': 'NCT02371369', 'acronym': 'ENLIVEN', 'briefTitle': 'Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath', 'orgStudyIdInfo': {'id': 'PLX108-10'}, 'secondaryIdInfos': [{'id': '2014-000148-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Pexidartinib', 'description': 'Participants received blinded treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks', 'interventionNames': ['Drug: Pexidartinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 - Placebo', 'description': 'Participants received blinded treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - All Pexidartinib', 'description': 'Participants received pexidartinib in Part 1 and in Part 2 at their prescribed dose', 'interventionNames': ['Drug: Pexidartinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Placebo-Pexidartinib', 'description': 'Participants received placebo in Part 1 and pexidartinib in Part 2 at their prescribed dose', 'interventionNames': ['Drug: Pexidartinib', 'Drug: Placebo']}], 'interventions': [{'name': 'Pexidartinib', 'type': 'DRUG', 'otherNames': ['PLX3397', 'Pexidartinib hydrochloride (HCl)'], 'description': 'Each capsule contains 200 mg of pexidartinib for oral administration', 'armGroupLabels': ['Part 1 - Pexidartinib', 'Part 2 - All Pexidartinib', 'Part 2 - Placebo-Pexidartinib']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Capsule'], 'description': 'Placebo capsule matching pexidartinib capsule for oral administration', 'armGroupLabels': ['Part 1 - Placebo', 'Part 2 - Placebo-Pexidartinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': ': Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 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'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3000', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': 'M5G2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave 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Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'NW12BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW36JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Global Team Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}