Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 6:31 PM
Study NCT ID:
NCT02601950
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013584', 'term': 'Sarcoma, Synovial'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593333', 'term': 'tazemetostat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@epizyme.com', 'phone': '(855) 500-1011', 'title': 'Medical Lead or Designee', 'organization': 'Epizyme, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.', 'description': 'Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 27, 'seriousNumAtRisk': 32, 'deathsNumAffected': 9, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 28, 'seriousNumAtRisk': 33, 'deathsNumAffected': 2, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Other INI1-Negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.", 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 29, 'seriousNumAtRisk': 32, 'deathsNumAffected': 5, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 3, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 58, 'seriousNumAtRisk': 62, 'deathsNumAffected': 8, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 65, 'seriousNumAtRisk': 69, 'deathsNumAffected': 6, 'seriousNumAffected': 19}, {'id': 'EG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 43, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 38, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 27, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG002', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG003', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '25.0'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '16.1', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '27.7'}, {'value': '15.9', 'groupId': 'OG004', 'lowerLimit': '8.2', 'upperLimit': '26.7'}, {'value': '5.6', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '27.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '31.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 16 Weeks', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 16 week was estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'PRIMARY', 'title': 'Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeks', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '32.1'}, {'value': '80.1', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '87.6'}, {'value': '88.0', 'groupId': 'OG004', 'lowerLimit': '7.1', 'upperLimit': '224.4'}, {'value': '96.1', 'groupId': 'OG005', 'lowerLimit': '10.3', 'upperLimit': '112.3'}, {'value': '151.6', 'groupId': 'OG006', 'lowerLimit': '151.6', 'upperLimit': '151.6'}, {'value': '119.4', 'groupId': 'OG007', 'lowerLimit': '119.4', 'upperLimit': '119.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)', 'description': 'DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat. Only those participants with a confirmed CR or PR (responders) were analyzed.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '15.1'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '8.1'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '31.7'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '15.1'}, {'value': '23.7', 'groupId': 'OG004', 'lowerLimit': '14.7', 'upperLimit': '25.7'}, {'value': '16.1', 'groupId': 'OG005', 'lowerLimit': '8.4', 'upperLimit': '16.6'}, {'value': '24.0', 'groupId': 'OG006', 'lowerLimit': '6.3', 'upperLimit': '175.3'}, {'value': '39.9', 'comment': 'NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.', 'groupId': 'OG007', 'lowerLimit': '4.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '33.1'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '32.0'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '18.2', 'upperLimit': '51.2'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '38.8'}, {'value': '42.1', 'groupId': 'OG004', 'lowerLimit': '29.3', 'upperLimit': '54.4'}, {'value': '33.8', 'groupId': 'OG005', 'lowerLimit': '22.9', 'upperLimit': '45.0'}, {'value': '43.6', 'groupId': 'OG006', 'lowerLimit': '18.2', 'upperLimit': '66.7'}, {'value': '53.6', 'groupId': 'OG007', 'lowerLimit': '13.2', 'upperLimit': '82.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '28.9'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '26.7'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '12.3', 'upperLimit': '43.5'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '38.8'}, {'value': '29.1', 'groupId': 'OG004', 'lowerLimit': '17.9', 'upperLimit': '41.2'}, {'value': '29.3', 'groupId': 'OG005', 'lowerLimit': '19.1', 'upperLimit': '40.4'}, {'value': '43.6', 'groupId': 'OG006', 'lowerLimit': '18.2', 'upperLimit': '66.7'}, {'value': '53.6', 'groupId': 'OG007', 'lowerLimit': '13.2', 'upperLimit': '82.5'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '15.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '29.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '21.3', 'groupId': 'OG004', 'lowerLimit': '11.6', 'upperLimit': '33.0'}, {'value': '22.6', 'groupId': 'OG005', 'lowerLimit': '13.3', 'upperLimit': '33.3'}, {'value': '18.2', 'groupId': 'OG006', 'lowerLimit': '1.5', 'upperLimit': '50.3'}, {'value': '26.8', 'groupId': 'OG007', 'lowerLimit': '1.3', 'upperLimit': '67.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 24, 32 and 56', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 24, 32 and 56 weeks were estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '54.6'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '58.1'}, {'value': '37.9', 'groupId': 'OG002', 'lowerLimit': '23.3', 'upperLimit': '104.0'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '73.6'}, {'value': '82.4', 'groupId': 'OG004', 'lowerLimit': '47.4', 'upperLimit': '117.0'}, {'value': '111.4', 'comment': 'NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.', 'groupId': 'OG005', 'lowerLimit': '63.0', 'upperLimit': 'NA'}, {'value': '77.7', 'comment': 'NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.', 'groupId': 'OG006', 'lowerLimit': '32.9', 'upperLimit': 'NA'}, {'value': '49.6', 'comment': 'NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.', 'groupId': 'OG007', 'lowerLimit': '19.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '61.6'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '63.2', 'upperLimit': '91.2'}, {'value': '68.8', 'groupId': 'OG002', 'lowerLimit': '49.7', 'upperLimit': '81.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '22.9', 'upperLimit': '72.2'}, {'value': '85.5', 'groupId': 'OG004', 'lowerLimit': '73.9', 'upperLimit': '92.2'}, {'value': '83.6', 'groupId': 'OG005', 'lowerLimit': '72.3', 'upperLimit': '90.6'}, {'value': '88.9', 'groupId': 'OG006', 'lowerLimit': '62.4', 'upperLimit': '97.1'}, {'value': '83.3', 'groupId': 'OG007', 'lowerLimit': '27.3', 'upperLimit': '97.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '55.2'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '49.9', 'upperLimit': '81.9'}, {'value': '56.3', 'groupId': 'OG002', 'lowerLimit': '37.6', 'upperLimit': '71.3'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '66.0'}, {'value': '77.2', 'groupId': 'OG004', 'lowerLimit': '64.6', 'upperLimit': '85.8'}, {'value': '75.8', 'groupId': 'OG005', 'lowerLimit': '63.6', 'upperLimit': '84.4'}, {'value': '77.8', 'groupId': 'OG006', 'lowerLimit': '51.1', 'upperLimit': '91.0'}, {'value': '66.7', 'groupId': 'OG007', 'lowerLimit': '19.5', 'upperLimit': '90.4'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '47.7'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '53.8'}, {'value': '49.6', 'groupId': 'OG002', 'lowerLimit': '31.4', 'upperLimit': '65.4'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '59.4'}, {'value': '57.3', 'groupId': 'OG004', 'lowerLimit': '43.9', 'upperLimit': '68.6'}, {'value': '66.5', 'groupId': 'OG005', 'lowerLimit': '53.7', 'upperLimit': '76.6'}, {'value': '55.6', 'groupId': 'OG006', 'lowerLimit': '30.5', 'upperLimit': '74.8'}, {'value': '44.4', 'groupId': 'OG007', 'lowerLimit': '6.6', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 24, 32 and 56', 'description': 'OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause. OS rate at 24, 32 and 56 weeks were estimated. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'SECONDARY', 'title': 'All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'OG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '40.0'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '31.9'}, {'value': '40.6', 'groupId': 'OG002', 'lowerLimit': '23.7', 'upperLimit': '59.4'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '45.2', 'groupId': 'OG004', 'lowerLimit': '32.5', 'upperLimit': '58.3'}, {'value': '36.2', 'groupId': 'OG005', 'lowerLimit': '25.0', 'upperLimit': '48.7'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '26.0', 'upperLimit': '74.0'}, {'value': '42.9', 'groupId': 'OG007', 'lowerLimit': '9.9', 'upperLimit': '81.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '29.0'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '24.3'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '40.0'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '29.0', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '41.9'}, {'value': '30.4', 'groupId': 'OG005', 'lowerLimit': '19.9', 'upperLimit': '42.7'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '13.3', 'upperLimit': '59.0'}, {'value': '42.9', 'groupId': 'OG007', 'lowerLimit': '9.9', 'upperLimit': '81.6'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '25.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.8'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '7.2', 'upperLimit': '36.4'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '25.8', 'groupId': 'OG004', 'lowerLimit': '15.5', 'upperLimit': '38.5'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '18.7', 'upperLimit': '41.2'}, {'value': '27.8', 'groupId': 'OG006', 'lowerLimit': '9.7', 'upperLimit': '53.5'}, {'value': '14.3', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '25.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.8'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '29.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '24.2', 'groupId': 'OG004', 'lowerLimit': '14.2', 'upperLimit': '36.7'}, {'value': '23.2', 'groupId': 'OG005', 'lowerLimit': '13.9', 'upperLimit': '34.9'}, {'value': '11.1', 'groupId': 'OG006', 'lowerLimit': '1.4', 'upperLimit': '34.7'}, {'value': '14.3', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 12, 24, 32 and 48', 'description': 'DCR was defined as the percentage of participants who achieved a confirmed response (CR or PR, as per RECIST v 1.1 criteria) or who have SD lasting at least 32 weeks from the start of treatment until disease progression or the start of subsequent anti-cancer therapy. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. SD was defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}, {'type': 'SECONDARY', 'title': 'Cohorts 2 and 8: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'OG001', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.6'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'ORR was defined as percentage of participants who achieved a confirmed CR or PR based on investigator assessment from start of treatment until PD or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per RANO criteria for primary brain tumors or RECIST v 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of tazemetostat.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (malignant rhabdoid tumor \\[MRT\\], rhabdoid tumors of the kidney \\[RTK\\], atypical teratoid rhabdoid tumor \\[ATRT\\], and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type \\[SCCOHT\\], also known as malignant rhabdoid tumor of the ovary \\[MRTO\\]) received tazemetostat 800 milligram (mg) twice daily (BID) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other integrase interactor 1 (INI-1)-negative tumors or any solid tumor with enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'FG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with renal medullary carcinoma (RMC) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG004', 'title': 'ES: Cohort 5', 'description': 'Participants with epithelioid sarcoma (ES) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumor biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'FG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg once daily (QD) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '69'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '69'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Participant enrolled in rollover study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Disease progression - radiological', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'Disease progression - clinical', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Unacceptable toxicity (related to study treatment)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse event (not related to study treatment)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Participant refused further study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Investigator discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This Phase II, open-label study was conducted at 28 sites in 9 countries (Australia, Belgium, Canada, France, Germany, Italy, Taiwan, United Kingdom, and United States) from 22 December 2015 to 26 February 2024.', 'preAssignmentDetails': 'Participants were enrolled into 1 of the 8 cohorts based on tumor type. A total of 267 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '267', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Rhabdoid Tumors: Cohort 1', 'description': 'Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG001', 'title': 'Synovial Sarcoma: Cohort 2', 'description': 'Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG002', 'title': 'Other INI1-negative: Cohort 3', 'description': "Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study."}, {'id': 'BG003', 'title': 'RMC: Cohort 4', 'description': 'Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG004', 'title': 'ES: Cohort 5', 'description': 'Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG005', 'title': 'ES Paired Biopsy: Cohort 6', 'description': 'Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG006', 'title': 'Chordoma: Cohort 7', 'description': 'Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG007', 'title': 'ES 1600 mg: Cohort 8', 'description': 'Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '16.31', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '9.54', 'groupId': 'BG001'}, {'value': '46.9', 'spread': '16.94', 'groupId': 'BG002'}, {'value': '30.7', 'spread': '10.71', 'groupId': 'BG003'}, {'value': '37.0', 'spread': '15.08', 'groupId': 'BG004'}, {'value': '41.3', 'spread': '14.00', 'groupId': 'BG005'}, {'value': '38.9', 'spread': '17.49', 'groupId': 'BG006'}, {'value': '40.9', 'spread': '15.74', 'groupId': 'BG007'}, {'value': '39.5', 'spread': '14.89', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '113', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '154', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '231', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '200', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who received at least 1 dose of tazemetostat.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-10', 'size': 16574767, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-27T02:39', 'hasProtocol': True}, {'date': '2023-09-12', 'size': 4275946, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-27T02:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2015-10-21', 'resultsFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-18', 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.'}, {'measure': 'Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat', 'timeFrame': 'At 16 Weeks', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 16 week was estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.'}, {'measure': 'Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeks', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous.'}], 'secondaryOutcomes': [{'measure': 'All Cohorts: Duration of Response (DOR)', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)', 'description': 'DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.'}, {'measure': 'All Cohorts: Progression-Free Survival (PFS)', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.'}, {'measure': 'All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56', 'timeFrame': 'At Weeks 24, 32 and 56', 'description': 'PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 24, 32 and 56 weeks were estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.'}, {'measure': 'All Cohorts: Overall Survival (OS)', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause.'}, {'measure': 'All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56', 'timeFrame': 'At Weeks 24, 32 and 56', 'description': 'OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause. OS rate at 24, 32 and 56 weeks were estimated. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.'}, {'measure': 'All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48', 'timeFrame': 'At Weeks 12, 24, 32 and 48', 'description': 'DCR was defined as the percentage of participants who achieved a confirmed response (CR or PR, as per RECIST v 1.1 criteria) or who have SD lasting at least 32 weeks from the start of treatment until disease progression or the start of subsequent anti-cancer therapy. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. SD was defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.'}, {'measure': 'Cohorts 2 and 8: Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)', 'description': 'ORR was defined as percentage of participants who achieved a confirmed CR or PR based on investigator assessment from start of treatment until PD or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per RANO criteria for primary brain tumors or RECIST v 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Rhabdoid Tumors (MRT)', 'Rhabdoid Tumors of the Kidney (RTK)', 'Atypical Teratoid Rhabdoid Tumors (ATRT)', 'Selected Tumors With Rhabdoid Features', 'Synovial Sarcoma', 'INI1-negative Tumors', 'Malignant Rhabdoid Tumor of Ovary', 'Renal Medullary Carcinoma', 'Epithelioid Sarcoma', 'Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval)', 'Any Solid Tumor With an EZH2 GOF Mutation']}, 'referencesModule': {'references': [{'pmid': '33035459', 'type': 'DERIVED', 'citation': 'Gounder M, Schoffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020 Nov;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. Epub 2020 Oct 6.'}], 'seeAlsoLinks': [{'url': 'https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2025/02/26115902/ezh202-lay-results-summary-EN.pdf', 'label': 'Lay language results summary'}]}, 'descriptionModule': {'briefSummary': 'This study will include participants with various types of cancer known as soft-tissue sarcomas.\n\nTissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments.\n\nSoft tissue cancers are rare and can occur almost anywhere in the body.\n\nPart 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability).\n\nIt is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).', 'detailedDescription': "This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts:\n\nCohort using tazemetostat 800 mg BID\n\n* Cohort 1 (Closed for enrollment): malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid rhabdoid tumor (ATRT), and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type (SCCOHT), also known as malignant rhaboid tumor of the ovary (MRTO)\n* Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement\n* Cohort 3 (Closed for enrollment): Other integrase interactor 1 (INI1) negative tumors or any solid tumor with an enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma\n* Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)\n* Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)\n* Cohort 6 (Closed for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy\n* Cohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)\n\nCohort using tazemetostat 1600 mg QD\n\n• Cohort 8 (Closed for enrollment): Epitheliod sarcoma\n\nParticipants will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study.\n\nTreatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age (at the time of consent/assent): ≥18 years of age\n2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n3. Has provided signed written informed consent\n4. Has a life expectancy of \\>3 months\n5. Has a malignancy:\n\n * For which there are no standard therapies available (Cohorts 1, 3, 4 and 5)\n * That is relapsed or refractory after treatment with an approved therapy(ies), defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies) (Cohort 2)\n\n * That has progressed within 6 months prior to study enrollment (Cohort 5 Expansion, Cohort 6 and Cohort 8 ONLY)\n6. Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA/College of American Pathologists (CAP) or equivalent laboratory certification\n7. For Cohort 1 (rhabdoid tumors only), the following test results must be available by local laboratory: morphology and immunophenotypic panel consistent with rhabdoid tumors, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable\n8. For Cohort 2 (subjects with relapsed/refractory synovial sarcoma only), the following tests must be available by local laboratory: Morphology consistent with synovial sarcomas, and cytogenetics or fluorescence in situ hybridization (FISH) and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)\n9. For Cohort 3, 4, 5, 7 and 8 (subjects with INI1-negative/aberrant tumors or any solid tumor with EZH2 GOF mutation only), the following test results must be available by local laboratory: Morphology and immunophenotypic panel consistent with INI1-negative tumors (not applicable for solid tumors with EZH2 GOF mutation), and loss of INI1 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable, or molecular evidence of EZH2 GOF mutation\n10. For Cohort 6 (subjects with ES undergoing optional tumor biopsy) only:\n\n * Morphology and immunophenotypic panel consistent with ES (e.g., CD34, EMA, Keratin, and INI1)\n11. Has all prior treatment (i.e. chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤Grade 1 per CTCAE version 4.0.3 or are clinically stable and not clinically significant, at time of enrollment.\n12. Prior anti-cancer therapy(ies), if applicable, must be completed according to the criteria below:\n\n * Chemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat)\n * Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)\n * Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)\n * Monoclonal antibody(ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat)\n * Immunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)\n * Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ≥50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)\n * High dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat)\n * Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)\n13. Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing\n14. Has measurable disease based on either RECIST 1.1 for solid tumors or RANO for CNS tumors\n15. Has adequate hematologic (bone marrow \\[BM\\] and coagulation factors), renal and hepatic function.\n16. For subjects with CNS Tumors only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat\n17. Has a shortening fraction of \\>27% or an ejection fraction of ≥50% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan and New York Heart Association (NYHA) Class ≤2\n18. Has a QT interval corrected by Fridericia's formula (QTcF) ≤480 msec\n19. Female subjects of childbearing potential must:\n\n * Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat and\n * Agree to use effective contraception from a minimum of 7 days prior to first dose until 6 months following the last dose of tazemetostat and have a male partner who uses a condom, or\n * Practice true abstinence or have a male partner who is vasectomized\n20. Male subjects with a female partner of childbearing potential must:\n\n * Be vasectomized, or\n * Agree to use condoms as defined in Section 8.6.2, from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or\n * Have a female partner who is NOT of childbearing potential\n\nExclusion Criteria:\n\n1. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2)\n2. Has participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of tazemetostat\n3. Has known active CNS or any leptomeningeal metastasis of primary extra-cranial tumor.\n4. Has had a prior malignancy other than the malignancies under study - EXCEPTION: A subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible\n5. Has had major surgery within 3 weeks prior to enrollment\n6. Has Thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 4.03 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS). Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing.\n7. Has a prior history of T-LBL /T-ALL\n8. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet\n9. Has cardiovascular impairment, history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the planned first dose of tazemetostat; or ventricular cardiac arrhythmia requiring medical treatment\n10. Is currently taking any prohibited medication(s)\n11. Has an active infection requiring systemic treatment\n12. Is immunocompromised (i.e. has congenital immunodeficiency), including subjects known history of infection with human immunodeficiency virus (HIV)\n13. Has known active infection with hepatitis B virus or hepatitis C virus\n14. Has had a symptomatic venous thrombosis within 2 weeks prior to study enrollment -\n15. For subjects with CNS involvement (primary tumor or metastatic disease), have any active bleeding or new intratumoral hemorrhage of more than punctuate size of screening MRI obtained within 14 days of starting study drug or known bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents\n16. Has known hypersensitivity to any of the component of tazemetostat or other inhibitor(s)of EZH2\n17. Is unable to take oral medications, or has a malabsorption syndrome or any uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that would limit compliance with study requirements.\n18. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.\n19. For female subjects of childbearing potential: Is pregnant or nursing\n20. For male subjects: Is unwilling to adhere to contraception criteria from time of enrollment in the study to at least 3 months after last dose of tazemetostat."}, 'identificationModule': {'nctId': 'NCT02601950', 'briefTitle': 'A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma', 'orgStudyIdInfo': {'id': 'EZH-202'}, 'secondaryIdInfos': [{'id': '2015-002469-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label Tazemetostat', 'description': 'All cohorts will receive 800 mg oral Tazemetostat twice a day in continuous 28-day cycles.', 'interventionNames': ['Drug: Tazemetostat']}], 'interventions': [{'name': 'Tazemetostat', 'type': 'DRUG', 'otherNames': ['EPZ-6438', 'E7438', 'IPN60200'], 'description': 'Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene', 'armGroupLabels': ['Open-label Tazemetostat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital - Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', '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': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Chris O'Brien Lifehouse", 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': 'QLD 4102', 'city': 'Woolloongabba', 'country': 'Australia', 'facility': 'Metro South Hospital and Health Service via Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet Medical Oncology Clinic', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre - Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': "Children's Hospital Augsburg Klinikum", 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Sarcoma Center HELIOS Klinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Instituto Nazionale Tumori - National Cancer Institute Via Giacomo Venezian', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.\n\nPatient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epizyme, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}