Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT03214666
Status:
TERMINATED
Last Update Posted:
2022-11-10
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gb@gtbiopharma.com', 'phone': '925-719-3531', 'title': 'Dr. Gregory Berk', 'organization': 'GT Biopharma, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This trial was terminated due to plans to clinically advance a modified second generation TriKE, requiring a new phase 1 study. Given this early termination, the maximal tolerated dose was not reached and the study did not proceed to phase 2. As only 12 participants were enrolled, the outcomes are presented in summary/descriptive format only.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.', 'description': 'Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.', 'eventGroups': [{'id': 'EG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anemia', 'notes': 'Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'LDH Increase', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'C-reactive protein increase', 'notes': 'Grade 1 Count: 1 (Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile neutropenia', 'notes': 'Grade 3 Count: 10 (6 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'notes': 'Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'notes': 'Grade 1 Count: 1 Grade 2 Count: 1 Unrelated to GTB-3550', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea', 'notes': 'Grade 1 Count: 3 (1 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flatulence', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastroesophageal reflux disease', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gingival bleeding/blood blister', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gingival pain', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'notes': 'Grade 2 Count: 2 Grade 1 Count: 1 Unrelated/unlikely related to GTB-3550', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chills', 'notes': 'Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'notes': 'Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'notes': 'Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'notes': 'Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'IL-6 Increase', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chloride increased', 'notes': 'Grade 1 Count: 2 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Allergic reaction', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cytokine release syndrome', 'notes': 'Grade 1 Count: 2 (1 possibly and 1 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'notes': 'Grade 1 Count: Mild (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'notes': 'Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alkaline phosphatase increased', 'notes': 'Grade 1 Count: 5 (1 possibly and 1 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspartate aminotransferase increased', 'notes': 'Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 2 (2 Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'notes': 'Grade 1 Count: 4 (1 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'notes': 'Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'INR increased', 'notes': 'Grade 1 Count: 1 (unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'IL-6 increase', 'notes': 'Grade 1 Count: 1 (Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'LDH elevated - intermittent', 'notes': 'Grade 1 Count: 1 (unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ferritin elevation', 'notes': 'Grade 1 Count: 1 (unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'CRP elevation', 'notes': 'Grade 1 Count: 3 (1 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fibrinogen elevation', 'notes': 'Grade 1 Count: 1 (unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chloride increase - intermittent', 'notes': 'Grade 1 Count: 2 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte count decreased', 'notes': 'Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'notes': 'Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'notes': 'Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'notes': 'Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperkalemia', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypermagnesemia', 'notes': 'Grade 1 Count: 4 (Unrelated or unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperphosphatemia', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoalbuminemia', 'notes': 'Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'notes': 'Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 2 Count: 3 (1 possibly and 1 probably related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypomagnesemia', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypophosphatemia', 'notes': 'Grade 1 Count: 1 (Possibly related to GTB-3550) Grade 2 Count: 2 (1 Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle spasms, intermittent', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myalgia', 'notes': 'Grade 2 Count: 2 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'notes': 'Grade 2 Count: 3 (Unrelated or unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'notes': 'Grade 1 Count: 1 (Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'notes': 'Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lethargy', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Memory impairment', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Insomnia', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Restlesness', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chronic kidney disease', 'notes': 'Grade 2 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary incontinence', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cough', 'notes': 'Grade 1 Count: 2 (Unrelated or unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'notes': 'Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoxia', 'notes': 'Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'notes': 'Grade 2 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'On oxygen with no documented hypoxia, intermittent', 'notes': 'Grade 2 Count: 1 (Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus disorder', 'notes': 'Grade 1 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash maculo-papular', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash - L leg', 'notes': 'Grade 1 Count: 1 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flushing', 'notes': 'Grade 1 Count: 1 (Possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypertension', 'notes': 'Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'notes': 'Grade 1 Count: 9 (8 possibly and 1 probably related to GTB-3550) Grade 2 Count: 3 (3 possibly related to GTB-3550)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'notes': 'All Grade 3; 2 possibly related to GTB-3550', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lung Infection', 'notes': 'Grade 3; Unlikely related to GTB-3550', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin Infection', 'notes': 'Grade 3; Unrelated to GTB-3550', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'GTB-3550 Dosing Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component)', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.'}], 'classes': [{'categories': [{'title': '5 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '10 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '25 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '50 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '100 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '150 ug/kg/day Dose', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (start of GTB-3550 therapy)', 'description': 'The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'GTB-3550 Extent of Treatment (Summary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}], 'classes': [{'categories': [{'title': 'Number of Participants Completing Blocks 1-3', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'Number of Participants Completing Only Blocks 1 and 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28 relative to the start of GTB-3550 therapy', 'description': 'This outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'units': 'TEAEs Regardless of Relationship', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '113', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}], 'classes': [{'title': 'Unexpected and Related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Unexpected and Related Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 relative to the start of GTB-3550 therapy', 'description': 'The number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'TEAEs Regardless of Relationship', 'denomUnitsSelected': 'TEAEs Regardless of Relationship'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Number of patients surviving at 6 months post-treatment on this study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Day 28 Relative to GTB-3550 Therapy', 'description': 'Blast count was measured at the time of standard of care disease assessment after GTB-3550 therapy. Blast percent was assessed by morphology and/or flow cytometry.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'OG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-4 weeks after completion of the 1st cycle of therapy', 'description': "Participants with lack of disease progression or evidence of a clinical improvement had the opportunity to receive an optional 2nd cycle of therapy ('retreatment').", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}, {'id': 'FG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}, {'id': 'FG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}, {'id': 'FG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}, {'id': 'FG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}, {'id': 'FG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.'}], 'periods': [{'title': 'Cohort 1: Dose Level 1: 5 ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT 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'}]}]}, {'title': 'Cohort 2: Dose Level 2: 10ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT 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'}]}]}, {'title': 'Cohort 3: Dose Level 3: 25 ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT 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'}]}]}, {'title': 'Cohort 4: Dose Level 4: 50 ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT 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'}]}]}, {'title': 'Cohort 5: Dose Level 5: 100 ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Cohort 6: Dose Level 6: 150 ug/kg/Day', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'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': '2'}]}, {'type': 'NOT 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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG001', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG002', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG003', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG004', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG005', 'title': 'GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day', 'description': 'Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.'}, {'id': 'BG006', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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'}]}, {'title': 'Asian', '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'}]}, {'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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', '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'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Disease', 'classes': [{'categories': [{'title': 'Relapsed/Refractory Acute Myeloid Leukemia (AML) - Secondary AML', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Relapsed/Refractory AML - de novo AML', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Relapsed/Refractory AML - Treatment-related', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Myelodysplastic Syndrome (MDS)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior Lines of Cancer Therapy', 'classes': [{'categories': [{'title': '2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': '4', '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': '1', 'groupId': 'BG006'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': '9', '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': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of prior lines of cancer therapies include therapies to treat any cancer diagnosis.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-04', 'size': 9562199, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-07T10:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2017-07-07', 'resultsFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2017-07-10', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-14', 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GTB-3550 Dosing Summary', 'timeFrame': 'Day 1 (start of GTB-3550 therapy)', 'description': 'The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550.'}, {'measure': 'GTB-3550 Extent of Treatment (Summary)', 'timeFrame': 'Day 28 relative to the start of GTB-3550 therapy', 'description': 'This outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]', 'timeFrame': 'Day 28 relative to the start of GTB-3550 therapy', 'description': 'The number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '6 Months', 'description': 'Number of patients surviving at 6 months post-treatment on this study.'}, {'measure': 'Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy', 'timeFrame': 'After Day 28 Relative to GTB-3550 Therapy', 'description': 'Blast count was measured at the time of standard of care disease assessment after GTB-3550 therapy. Blast percent was assessed by morphology and/or flow cytometry.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes (MDS)', 'Acute Myeloid Leukemia (AML)'], 'conditions': ['High-risk Myelodysplastic Syndromes', 'Acute Myelogenous Leukemia', 'Systemic Mastocytosis', 'Mast Cell Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The hypothesis is that GTB-3550 TriKE® will induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is the most potent activating receptor on natural killer (NK) cells, this single agent may induce a targeted anti-CD33+ tumor response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Eligible Diseases\n\n* Diagnosis of one of the following CD33-expressing myeloid malignancies with greater than or equal to 50% CD33+ target cells with no good standard of care treatment options including:\n* High Risk Myelodysplastic Syndromes (MDS) progressive on two or more prior regimens and requiring treatment that meets at least one of the following:\n\n * Revised International Prognostic Scoring System (IPSS-R) High or Very High Risks\n * World Health Organization (WHO) Classification: Refractory anemia with excess blasts-1 (RAEB-1) or RAEB-2\n * Poor and very-poor risk cytogenetic abnormality as defined by the IPSS-R cytogenetic classifications\n * WHO Based Prognostic Scoring System (WPSS): High or Very High Risk\n* Therapy related MDS and not a candidate for induction chemotherapy or had an inadequate treatment response after induction chemotherapy.\n* Refractory or Relapsed Acute Myelogenous Leukemia (AML) meeting at least one of the following:\n\n * Refractory AML defined as failure to achieve remission after at least 3 induction attempts\n\n \\*\\* Elderly AML not fit for induction therapy can be enrolled after 2 failed inductions\n * Relapsed AML\n\n * Not a candidate for hematopoietic stem cell transplant (HSCT), at least one re-induction attempt required\n * Prior HSCT relapse beyond 3 months may be included only if off immunosuppression for a minimum of 4 weeks and do not have graft-versus-host disease (GVHD)\n* Advanced systemic mastocytosis (defined as mast cell leukemia, aggressive systemic mastocytosis, and systemic mastocytosis associated with hematologic neoplasm) may enroll without any prior treatment, given there is no standard established therapy.\n\nInclusion Criteria: Age, Performance Status, Organ Function, Contraception Use\n\n* At least 18 years of age\n* Karnofsky score ≥ 70%\n* Adequate organ function within 14 days (30 days for cardiac and pulmonary) of study enrollment defined as:\n\n * Renal: an estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2\n * Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin within normal range\n * Pulmonary function: Diffusing capacity for carbon monoxide (DLCO) corrected (ml/min/mm Hg) defined as no more than 5 units below lower limit of normal (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5 Grade 1 carbon monoxide diffusing capacity decreased) based on patient's height, weight, and gender as reported by the institutional pulmonary function lab.\n * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia; left ventricular ejection fraction ≥ 45% by echocardiogram, multigated acquisition (MUGA) scan or cardiac MRI.\n* Absolute lymphocyte count (ALC) ≥ 200 cells/mm³ OR absolute circulating CD56+/CD3- NK cell count \\>25 cells/μl within the 14 days prior to start of therapy\n* Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment\n* Participant provides voluntary written consent signed before performance of any study-related procedure not part of normal medical care\n\nExclusion Criteria\n\n* New or progressive pulmonary infiltrates on screening chest x-ray or chest computerized tomography (CT) scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving with associated clinical improvement after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).\n* Uncontrolled bacterial, fungal or viral infections, known history of HIV\n* Active Hepatitis B or Hepatitis C (virus detectable by polymerase chain reaction \\[PCR\\]) - chronic asymptomatic viral hepatitis is allowed\n* Other concurrent active cancer within the last year (excluding non-melanoma skin cancers)\n* Severely clinically obese patients, BMI \\>38\n* Currently taking any over-the-counter (OTC), vitamin, mineral, or dietary supplement within 14 days prior to study drug administration on Day 1 and during study conduct that may confound study safety goals (e.g., St. John's wort). Questions should be discussed with GT Biopharma.\n* Pregnant or breast feeding. The effect of GTB-3550 TriKE on the fetus is unknown. Females of childbearing potential must have a blood test within 7 days prior to enrollment to rule out pregnancy - must be repeated if not within 7 days of treatment initiation\n* History of central nervous system (CNS) malignancy or symptoms of active CNS disease\n* A family history of long QT syndrome or with a corrected QT (QTc) interval \\> 480 msec at screening\n* Currently taking medications known to prolong QT/QTc interval as the potential risk of QT/QTc prolongation is unknown in humans.\n* A candidate for potentially curative therapy, including hematopoietic cell transplant\n* Unwilling to remain within a 90 minute drive of the study center through at least Day 29"}, 'identificationModule': {'nctId': 'NCT03214666', 'briefTitle': 'GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'GT Biopharma, Inc.'}, 'officialTitle': 'GTB-3550 (CD16/IL-15/CD33)Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced Systemic Mastocytosis', 'orgStudyIdInfo': {'id': '2015LS167'}, 'secondaryIdInfos': [{'id': 'HM2015-39', 'type': 'OTHER', 'domain': 'University of Minnesota Masonic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GTB-3550 TriKE® (Phase I: Dose Finding Component)', 'description': 'Patients receive a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Each block consists of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment is given as an inpatient. The assigned dose will be calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose is not be recalculated for subsequent treatment blocks.', 'interventionNames': ['Drug: GTB-3550 TriKE® Phase I']}, {'type': 'EXPERIMENTAL', 'label': 'GTB-3550 TriKE® Only (Phase II: Extended Component)', 'description': "The treatment schedule is identical to the dose finding component. The extended component uses a Simon's MiniMax two-stage design for continued enrollment using the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.", 'interventionNames': ['Drug: GTB-3550 TriKE® Phase II']}], 'interventions': [{'name': 'GTB-3550 TriKE® Phase I', 'type': 'DRUG', 'otherNames': ['CD16/IL-15/CD33'], 'description': 'The 1st two patients will be assigned Dose Level 1. The study statistician will assign each new cohort of 2 patients to the most appropriate dose level based on updated toxicity probabilities.\n\n* Dose Level 1 - 5 μg/kg/day\n* Dose Level 2 - 10 μg/kg/day\n* Dose Level 3 - 25 μg/kg/day\n* Dose Level 4 - 50 μg/kg/day\n* Dose Level 5 - 100 μg/kg/day\n* Dose Level 6 - 150 μg/kg/day\n* Dose Level 7 - 200 μg/kg/day', 'armGroupLabels': ['GTB-3550 TriKE® (Phase I: Dose Finding Component)']}, {'name': 'GTB-3550 TriKE® Phase II', 'type': 'DRUG', 'otherNames': ['CD16/IL-15/CD33'], 'description': 'Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.', 'armGroupLabels': ['GTB-3550 TriKE® Only (Phase II: Extended Component)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Clinical Science Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mark B Juckett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GT Biopharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}