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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 4:36 AM

Ignite Modification Date: 2026-03-11 @ 6:23 AM

Study NCT ID: NCT02959918

Status: COMPLETED

Last Update Posted: 2022-02-14

First Post: 2016-11-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ptraber@selectabiosciences.com', 'phone': '713-540-9776', 'title': 'Dr. Peter Traber', 'organization': 'Selecta Biosciences, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 months', 'eventGroups': [{'id': 'EG000', 'title': 'SEL-037 (Pegadricase) Low Dose', 'description': 'Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SEL-037 (Pegadricase) High Dose', 'description': 'Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG012', 'title': 'SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Gout flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 21, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Anaphylactic reaction', 'stats': 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{'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gout flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '12', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL-037 (Pegadricase) Low Dose', 'description': 'Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses'}, {'id': 'OG001', 'title': 'SEL-037 (Pegadricase) High Dose', 'description': 'Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses'}, {'id': 'OG002', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG003', 'title': 'SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG004', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG005', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG006', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG007', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG008', 'title': 'SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG009', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG010', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG011', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}, {'id': 'OG012', 'title': 'SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses', 'description': 'SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses'}, {'id': 'OG013', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '12', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Five monthly infusions', 'description': 'To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, dosed subjects'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL-037 (Pegadricase)', 'description': 'SEL-037 every 28 days for up to 5 doses'}, {'id': 'OG001', 'title': 'SEL-212 for 3 Doses Followed by SEL-037 for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 3 doses followed by SEL-037 every 28 days for 2 doses'}, {'id': 'OG002', 'title': 'SEL-212 for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 5 doses'}], 'classes': [{'title': 'Treatment Period 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Period 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No subjects in the arm were dosed during treatment period 5', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 5 months', 'description': 'Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \\< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible subjects are those who received the entire first dose, did not discontinue due to withdrawal of consent (during TP 1-4), a protocol deviation (during TP1-2) or a non-study drug-related SAE (during TP1-2). The outcome data is presented with arms combined by regimen (i.e. SEL-037 alone; SEL-212 for 3 doses \\& SEL-037 for 2 doses; or SEL-212 for 5 doses) rather than by dosing arm as the outcome is most effected by the SEL-212 combination which results in suppression of anti-drug antibodies.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SEL-037 (Pegadricase) Low Dose', 'description': 'Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses'}, {'id': 'OG001', 'title': 'SEL-037 (Pegadricase) High Dose', 'description': 'Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses'}, {'id': 'OG002', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG003', 'title': 'SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG004', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG005', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG006', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG007', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG008', 'title': 'SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG009', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'OG010', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'OG011', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}, {'id': 'OG012', 'title': 'SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses', 'description': 'SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses'}, {'id': 'OG013', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}], 'classes': [{'title': 'Treatment Period 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}]}, {'title': 'Treatment Period 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No subjects in the arm were dosed during treatment period 5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No subjects in the arm were dosed during treatment period 5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 5 months', 'description': 'Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \\< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SEL-037 (Pegadricase) Low Dose', 'description': 'Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses'}, {'id': 'FG001', 'title': 'SEL-037 (Pegadricase) High Dose', 'description': 'Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses'}, {'id': 'FG002', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'FG003', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'FG004', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'FG005', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'FG006', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'FG007', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'FG008', 'title': 'SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'FG009', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'FG010', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'FG011', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}, {'id': 'FG012', 'title': 'SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 dose then SEL-110 (0.1 mg/kg) + Pegadricase 0.2 mg/kg every 28 days for 4 doses'}, {'id': 'FG013', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '14'}, {'groupId': 'FG009', 'numSubjects': '13'}, {'groupId': 'FG010', 'numSubjects': '14'}, {'groupId': 'FG011', 'numSubjects': '23'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '12'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'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'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Stopping Rule Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision, Pause in Clinical Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Subject Hospitalized, out of window for next dosing period', 'reasons': [{'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': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'PI Discretion due to abnormal Hgb results', 'reasons': [{'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'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Subject under-dosed with study drug and removed by Sponsor', 'reasons': [{'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'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '12', 'groupId': 'BG013'}, {'value': '152', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'SEL-037 (Pegadricase) Low Dose', 'description': 'Pegardricase 0.2 mg/kg every 28 days for up to 5 doses'}, {'id': 'BG001', 'title': 'SEL-037 (Pegadricase) High Dose', 'description': 'Pegardricase 0.4 mg/kg every 28 days for up to 5 doses'}, {'id': 'BG002', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'BG003', 'title': 'SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'BG004', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'BG005', 'title': 'SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'BG006', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'BG007', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'BG008', 'title': 'SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'BG009', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses'}, {'id': 'BG010', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses'}, {'id': 'BG011', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}, {'id': 'BG012', 'title': 'SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses', 'description': 'SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 Dose Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 4 Doses'}, {'id': 'BG013', 'title': 'SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses', 'description': 'SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '126', 'groupId': 'BG014'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '26', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '14', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '22', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '12', 'groupId': 'BG013'}, {'value': '138', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Number Analyzed', 'categories': [{'title': 'American Indian or Alaska Native', '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '40', 'groupId': 'BG014'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '14', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '103', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-19', 'size': 1965978, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-01T09:13', 'hasProtocol': True}, {'date': '2019-02-12', 'size': 1920845, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-01T09:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2016-11-06', 'resultsFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-31', 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set', 'timeFrame': 'Five monthly infusions', 'description': 'To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110', 'timeFrame': '3 and 5 months', 'description': 'Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \\< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gout Chronic', 'Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '37069364', 'type': 'DERIVED', 'citation': 'Kivitz A, DeHaan W, Azeem R, Park J, Rhodes S, Inshaw J, Leung SS, Nicolaou S, Johnston L, Kishimoto TK, Traber PG, Sands E, Choi H. Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110). Rheumatol Ther. 2023 Aug;10(4):825-847. doi: 10.1007/s40744-023-00546-0. Epub 2023 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.\n\nParticipants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.', 'detailedDescription': 'This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase ( SEL-037, also known as pegadricase) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in participants with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses (5 monthly IV infusions) of pegsiticase (SEL-037) alone.\n\nUricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. All participants will be monitored for safety and tolerability to drug throughout the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured include uric acid levels and levels of ADAs.\n\nThe study duration per enrolled participant will be approximately 6 months including a 1 month screening period followed by 5 treatment cycles and an end of treatment visit which will occur 30 days after the last IV infusion .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (age 21-75 inclusive) men and women of non child bearing potential with established or symptomatic gout which is defined as having at least ONE of any of the 3 following factors:\n\n 1. ≥ 1 tophus\n 2. 1 gout flare within the last 6 months\n 3. Chronic gouty arthropathy\n2. Screening serum uric acid of \\>6 mg/dL\n3. On a gout flare prophylactic regimen for 7 days prior to first dose\n4. Willing to provide written informed consent prior to first study procedure is performed.\n5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.\n\nExclusion Criteria:\n\n1. History of anaphylaxis or severe allergic reaction.\n2. History of an allergy to pegylated products.\n3. Women of child bearing potential, Defined as:\n\n * \\<6 weeks after surgical bilateral salpingooperhectony with or without hysterectomy\n * Pre or perimenopausal ( \\< less than 24 months of natural amenorrhea)\n4. Initiation or change in dose of hormone-replacement therapy for menopausal women less than 1 month prior to the Screening Visit or during the Screening Phase would be exclusionary. If after being on a stable dose of hormone-replacement therapy for one month the patient may be considered for the study if she continues to meet all other inclusion and exclusion criteria\n5. Uncontrolled diabetes with baseline HbA1c ≥8%;\n6. Glucose-6-phosphate dehydrogenase deficiency;\n7. Uncontrolled hypertension\n8. Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;\n9. History of coronary artery disease, including myocardial infarction;\n10. Congestive heart failure, New York Heart Association Class III or IV;\n11. ECG with evidence of prior myocardial infarction, clinically significant arrhythmia, or other abnormalities that, in the opinion of the investigator, are consistent with significant underlying cardiac disease;\n12. History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;\n13. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)\n14. History of malignancy within the last 5 years other than basal skin cancer;\n15. Subjects who, in the opinion of the investigator, present with a condition that would compromise their safety or that would make study completion unlikely.'}, 'identificationModule': {'nctId': 'NCT02959918', 'briefTitle': 'Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Selecta Biosciences, Inc.'}, 'officialTitle': 'An Open Label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 Followed by Open Label Administration of SEL-037 in Subjects With Symptomatic Gout and Elevated Blood Uric Acid', 'orgStudyIdInfo': {'id': 'SEL-212/201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEL-037 Pegadricase LD (low dose) alone', 'description': 'Pegadricase 0.2 mg/kg intravenous (IV) every 28 days for 5 treatments', 'interventionNames': ['Drug: SEL-037']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-037 Pegadricase HD (high dose) alone', 'description': 'Pegadricase 0.4 mg/kg intravenous (IV) every 28 days for 5 treatments', 'interventionNames': ['Drug: SEL-037']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase LD & SEL-110 (1a)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (1b)', 'description': 'Pegadricase 0.4 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase LD & SEL-110 (2a)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (2b)', 'description': 'Pegadricase 0.4 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (3a)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (3b)', 'description': 'Pegadricase 0.4 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (4a)', 'description': 'Pegadricase 0.4 mg/kg IV plus SEL-110 0.125 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (4b)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (5a)', 'description': 'Pegadricase 0.4 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (5b)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 5 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (6a)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.10 mg/kg IV every 28 days for 1 treatment followed by pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 4 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}, {'type': 'EXPERIMENTAL', 'label': 'SEL-212, Pegadricase HD & SEL-110 (6b)', 'description': 'Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 5 treatments', 'interventionNames': ['Drug: SEL-212', 'Drug: SVP-rapamycin (SEL-110)']}], 'interventions': [{'name': 'SEL-212', 'type': 'DRUG', 'otherNames': ['Pegadricase plus SVP-rapamycin'], 'description': 'SEL-212, biologic', 'armGroupLabels': ['SEL-212, Pegadricase HD & SEL-110 (1b)', 'SEL-212, Pegadricase HD & SEL-110 (2b)', 'SEL-212, Pegadricase HD & SEL-110 (3a)', 'SEL-212, Pegadricase HD & SEL-110 (3b)', 'SEL-212, Pegadricase HD & SEL-110 (4a)', 'SEL-212, Pegadricase HD & SEL-110 (4b)', 'SEL-212, Pegadricase HD & SEL-110 (5a)', 'SEL-212, Pegadricase HD & SEL-110 (5b)', 'SEL-212, Pegadricase HD & SEL-110 (6a)', 'SEL-212, Pegadricase HD & SEL-110 (6b)', 'SEL-212, Pegadricase LD & SEL-110 (1a)', 'SEL-212, Pegadricase LD & SEL-110 (2a)']}, {'name': 'SEL-037', 'type': 'DRUG', 'otherNames': ['Pegadricase'], 'description': 'SEL-037, biologic', 'armGroupLabels': ['SEL-037 Pegadricase HD (high dose) alone', 'SEL-037 Pegadricase LD (low dose) alone']}, {'name': 'SVP-rapamycin (SEL-110)', 'type': 'DRUG', 'otherNames': ['SEL-110'], 'description': 'SVP-rapamycin, biologic', 'armGroupLabels': ['SEL-212, Pegadricase HD & SEL-110 (1b)', 'SEL-212, Pegadricase HD & SEL-110 (2b)', 'SEL-212, 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