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Ignite Creation Date: 2025-12-24 @ 11:11 PM

Ignite Modification Date: 2025-12-25 @ 8:45 PM

Study NCT ID: NCT03541369

Status: TERMINATED

Last Update Posted: 2024-10-10

First Post: 2018-05-18

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the early termination of the study, the dose expansion cohort was not opened, and the secondary endpoint for duration of response which was pre-specified for the dose expansion cohort was not collected.'}}, 'adverseEventsModule': {'timeFrame': 'For all-cause mortality, from enrollment to end of study; median time on study was 1.347 months. Adverse events were reported from first dose of investigational product (day 1 cycle 1) to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months.', 'description': 'All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG018', 'title': 'Overall Studies', 'description': 'All participants included in all cohorts.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 64, 'seriousNumAtRisk': 64, 'deathsNumAffected': 14, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypofibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'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'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 1 to 28 for each cohort (28 days)', 'description': 'A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 except for cytokine release syndrome (CRS) grading:\n\n* drug-induced liver injury\n* any treatment-related death\n* Grade 2 CRS not resolving to ≤ grade 1 within 7 days; grade 3 CRS not resolving to ≤ grade 1 within 7 days; grade 3 CRS reported at the initial run-in dose; 2 separate grade 3 CRS events\n* Grade 4 CRS/infusion reactions\n* Grade 3-5 non-hematologic toxicity not clearly resulting from underlying leukemia except: alopecia, grade 3 rash, fatigue, asthenia, fever, anorexia, or constipation, nausea, vomiting or diarrhea not requiring tube feeding, total parenteral nutrition, or requiring/prolonging hospitalization; infection, bleeding, or other expected complication of cytopenias due to underlying leukemia; grade 3 infusion reaction including CRS; grade 3 tumor lysis syndrome\n* Grade 4 neutropenia persisting beyond 42 days in absence of leukemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT evaluable set included all DLT-evaluable participants, defined as participants who received the doses planned for the respective cohort, and completed the DLT window of 28 days for all cohorts unless they dropped out before completion of the DLT window for reasons other than a DLT. Exception: participant had received the planned doses in cycle 1 and dropped out within 1 week of the completion of the DLT period due to progressive disease, that participant was considered DLT-evaluable.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Cycle 1 to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.\n\nA TEAE was an AE that started on or after the first dose of investigational product (emirodatamab) up to 30 days after the end of investigational product or end of study date, whichever was earlier.\n\nA treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (emirodatamab).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For Cohorts 1-15, the safety analysis set included all participants who received at least 1 dose of emirodatamab. For cohorts 16 and 17, the safety analysis set included all participants who received at least 1 dose of emirodatamab or etanercept.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.0963', 'groupId': 'OG000', 'lowerLimit': '0.0963', 'upperLimit': '0.0963'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.116', 'groupId': 'OG002', 'lowerLimit': '0.116', 'upperLimit': '0.116'}, {'value': '0.0879', 'groupId': 'OG003', 'lowerLimit': '0.0879', 'upperLimit': '0.0879'}, {'value': '1.38', 'groupId': 'OG004', 'lowerLimit': '0.909', 'upperLimit': '5.19'}, {'value': '1.10', 'groupId': 'OG005', 'lowerLimit': '0.665', 'upperLimit': '7.15'}, {'value': '2.72', 'groupId': 'OG006', 'lowerLimit': '2.72', 'upperLimit': '2.72'}, {'value': '7.54', 'groupId': 'OG007', 'lowerLimit': '2.63', 'upperLimit': '42.3'}, {'value': '14.1', 'groupId': 'OG008', 'lowerLimit': '3.57', 'upperLimit': '28.4'}, {'value': '21.4', 'groupId': 'OG009', 'lowerLimit': '8.47', 'upperLimit': '77.2'}, {'value': '124', 'groupId': 'OG010', 'lowerLimit': '11.5', 'upperLimit': '137'}, {'value': '29.7', 'groupId': 'OG011', 'lowerLimit': '17.3', 'upperLimit': '180'}, {'value': '156', 'groupId': 'OG012', 'lowerLimit': '13.7', 'upperLimit': '355'}, {'value': '46.7', 'groupId': 'OG013', 'lowerLimit': '23.3', 'upperLimit': '276'}, {'value': '0.487', 'groupId': 'OG016', 'lowerLimit': '0.115', 'upperLimit': '2.38'}, {'value': '0.838', 'groupId': 'OG017', 'lowerLimit': '0.838', 'upperLimit': '0.838'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG014', 'lowerLimit': '4.92', 'upperLimit': '232'}, {'value': '36.7', 'groupId': 'OG015', 'lowerLimit': '13.0', 'upperLimit': '60.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: Cycle 1 Day 5 (C1D5); Cohorts 14 and 15: Cycle 1 Day 8 (C1D8) (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax (Tmax) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.2'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.88', 'upperLimit': '2.2'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '2.0'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '1.9'}, {'value': '1.1', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '1.1'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '1.6'}, {'value': '2.5', 'groupId': 'OG009', 'lowerLimit': '1.6', 'upperLimit': '2.6'}, {'value': '1.7', 'groupId': 'OG010', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG011', 'lowerLimit': '1.6', 'upperLimit': '2.6'}, {'value': '1.9', 'groupId': 'OG012', 'lowerLimit': '1.6', 'upperLimit': '2.6'}, {'value': '2.4', 'groupId': 'OG013', 'lowerLimit': '1.6', 'upperLimit': '2.7'}, {'value': '1.3', 'groupId': 'OG016', 'lowerLimit': '1.1', 'upperLimit': '2.6'}, {'value': '1.8', 'groupId': 'OG017', 'lowerLimit': '1.8', 'upperLimit': '1.8'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG014', 'lowerLimit': '1.5', 'upperLimit': '1.8'}, {'value': '1.9', 'groupId': 'OG015', 'lowerLimit': '1.7', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.0569'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.228'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '0.149'}, {'value': '0.0510', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '1.42'}, {'value': '0.434', 'groupId': 'OG009', 'lowerLimit': '0.0833', 'upperLimit': '2.79'}, {'value': '1.10', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '3.23'}, {'value': '0.301', 'groupId': 'OG011', 'lowerLimit': '0.231', 'upperLimit': '5.42'}, {'value': '0.228', 'groupId': 'OG012', 'lowerLimit': '0.00', 'upperLimit': '18.5'}, {'value': '0.00', 'groupId': 'OG013', 'lowerLimit': '0.00', 'upperLimit': '16.0'}, {'value': '0.00', 'groupId': 'OG016', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG017', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG014', 'lowerLimit': '0.00', 'upperLimit': '21.6'}, {'value': '0.253', 'groupId': 'OG015', 'lowerLimit': '0.253', 'upperLimit': '0.253'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.793', 'groupId': 'OG000', 'lowerLimit': '0.793', 'upperLimit': '0.793'}, {'value': '0.484', 'groupId': 'OG002', 'lowerLimit': '0.484', 'upperLimit': '0.484'}, {'value': '0.0894', 'groupId': 'OG003', 'lowerLimit': '0.0894', 'upperLimit': '0.0894'}, {'value': '24.9', 'groupId': 'OG004', 'lowerLimit': '12.1', 'upperLimit': '172'}, {'value': '15.1', 'groupId': 'OG005', 'lowerLimit': '5.89', 'upperLimit': '313'}, {'value': '26.8', 'groupId': 'OG006', 'lowerLimit': '26.8', 'upperLimit': '26.8'}, {'value': '75.5', 'groupId': 'OG007', 'lowerLimit': '38.0', 'upperLimit': '1110'}, {'value': '160', 'groupId': 'OG008', 'lowerLimit': '112', 'upperLimit': '1530'}, {'value': '345', 'groupId': 'OG009', 'lowerLimit': '282', 'upperLimit': '3400'}, {'value': '4590', 'groupId': 'OG010', 'lowerLimit': '122', 'upperLimit': '5900'}, {'value': '611', 'groupId': 'OG011', 'lowerLimit': '384', 'upperLimit': '6980'}, {'value': '1460', 'groupId': 'OG012', 'lowerLimit': '154', 'upperLimit': '14100'}, {'value': '288', 'groupId': 'OG013', 'lowerLimit': '250', 'upperLimit': '13100'}, {'value': '5.73', 'groupId': 'OG016', 'lowerLimit': '0.962', 'upperLimit': '23.7'}, {'value': '22.6', 'groupId': 'OG017', 'lowerLimit': '22.6', 'upperLimit': '22.6'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '3550', 'groupId': 'OG014', 'lowerLimit': '60.0', 'upperLimit': '11000'}, {'value': '464', 'groupId': 'OG015', 'lowerLimit': '170', 'upperLimit': '758'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. AUC(0-last) was calculated using the linear trapezoidal method.', 'unitOfMeasure': 'hour*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'AUC From Time 0 to Infinity (AUC0-inf) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG004', 'lowerLimit': '25.7', 'upperLimit': '176'}, {'value': '16.4', 'groupId': 'OG005', 'lowerLimit': '6.74', 'upperLimit': '332'}, {'value': '28.5', 'groupId': 'OG006', 'lowerLimit': '28.5', 'upperLimit': '28.5'}, {'value': '77.2', 'groupId': 'OG007', 'lowerLimit': '39.3', 'upperLimit': '1130'}, {'value': '169', 'groupId': 'OG008', 'lowerLimit': '114', 'upperLimit': '1680'}, {'value': '314', 'groupId': 'OG009', 'lowerLimit': '290', 'upperLimit': '3590'}, {'value': '4660', 'groupId': 'OG010', 'lowerLimit': '125', 'upperLimit': '6220'}, {'value': '631', 'groupId': 'OG011', 'lowerLimit': '403', 'upperLimit': '7410'}, {'value': '1460', 'groupId': 'OG012', 'lowerLimit': '160', 'upperLimit': '15900'}, {'value': '322', 'groupId': 'OG013', 'lowerLimit': '252', 'upperLimit': '14500'}, {'value': '17.4', 'groupId': 'OG016', 'lowerLimit': '17.4', 'upperLimit': '17.4'}, {'value': '25.2', 'groupId': 'OG017', 'lowerLimit': '25.2', 'upperLimit': '25.2'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '3940', 'groupId': 'OG014', 'lowerLimit': '61.4', 'upperLimit': '12400'}, {'value': '473', 'groupId': 'OG015', 'lowerLimit': '178', 'upperLimit': '767'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. The AUC(0-inf) was calculated using the linear trapezoidal method.', 'unitOfMeasure': 'hour*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'AUC From Time Zero to 14 Days Post-dose (AUC14d) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.454', 'groupId': 'OG000', 'lowerLimit': '0.454', 'upperLimit': '0.454'}, {'value': '0.0401', 'groupId': 'OG001', 'lowerLimit': '0.0401', 'upperLimit': '0.0401'}, {'value': '0.323', 'groupId': 'OG002', 'lowerLimit': '0.323', 'upperLimit': '0.323'}, {'value': '0.377', 'groupId': 'OG003', 'lowerLimit': '0.377', 'upperLimit': '0.377'}, {'value': '52.8', 'groupId': 'OG004', 'lowerLimit': '2.93', 'upperLimit': '262'}, {'value': '28.8', 'groupId': 'OG005', 'lowerLimit': '13.3', 'upperLimit': '523'}, {'value': '48.0', 'groupId': 'OG006', 'lowerLimit': '48.0', 'upperLimit': '48.0'}, {'value': '103', 'groupId': 'OG007', 'lowerLimit': '59.2', 'upperLimit': '1470'}, {'value': '237', 'groupId': 'OG008', 'lowerLimit': '139', 'upperLimit': '1770'}, {'value': '518', 'groupId': 'OG009', 'lowerLimit': '103', 'upperLimit': '4890'}, {'value': '5320', 'groupId': 'OG010', 'lowerLimit': '155', 'upperLimit': '7210'}, {'value': '762', 'groupId': 'OG011', 'lowerLimit': '489', 'upperLimit': '9250'}, {'value': '1670', 'groupId': 'OG012', 'lowerLimit': '215', 'upperLimit': '17700'}, {'value': '374', 'groupId': 'OG013', 'lowerLimit': '293', 'upperLimit': '15300'}, {'value': '5070', 'groupId': 'OG014', 'lowerLimit': '163', 'upperLimit': '17400'}, {'value': '923', 'groupId': 'OG015', 'lowerLimit': '676', 'upperLimit': '1170'}, {'value': '4.52', 'groupId': 'OG016', 'lowerLimit': '0.434', 'upperLimit': '38.2'}, {'value': '44.3', 'groupId': 'OG017', 'lowerLimit': '44.3', 'upperLimit': '44.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'For all cohorts: from time zero to 14-days following the C1D1 dose (1 cycle= 14 days)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. AUC(14d) was calculated as the sum of AUC values of all dosing days in cycle 1.', 'unitOfMeasure': 'hour*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2,z) of Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'title': 'C1D5 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG004', 'lowerLimit': '10.2', 'upperLimit': '49.7'}, {'value': '25.5', 'groupId': 'OG005', 'lowerLimit': '8.29', 'upperLimit': '55.3'}, {'value': '14.1', 'groupId': 'OG006', 'lowerLimit': '14.1', 'upperLimit': '14.1'}, {'value': '28.1', 'groupId': 'OG007', 'lowerLimit': '14.9', 'upperLimit': '52.9'}, {'value': '45.0', 'groupId': 'OG008', 'lowerLimit': '19.3', 'upperLimit': '75.7'}, {'value': '39.0', 'groupId': 'OG009', 'lowerLimit': '26.2', 'upperLimit': '46.9'}, {'value': '42.1', 'groupId': 'OG010', 'lowerLimit': '13.9', 'upperLimit': '68.5'}, {'value': '53.0', 'groupId': 'OG011', 'lowerLimit': '46.3', 'upperLimit': '56.9'}, {'value': '40.4', 'groupId': 'OG012', 'lowerLimit': '12.4', 'upperLimit': '66.2'}, {'value': '32.3', 'groupId': 'OG013', 'lowerLimit': '11.1', 'upperLimit': '57.4'}, {'value': '12.4', 'groupId': 'OG016', 'lowerLimit': '12.4', 'upperLimit': '12.4'}, {'value': '20.8', 'groupId': 'OG017', 'lowerLimit': '20.8', 'upperLimit': '20.8'}]}]}, {'title': 'C1D8 Free Emirodatamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG014', 'lowerLimit': '9.05', 'upperLimit': '62.6'}, {'value': '22.7', 'groupId': 'OG015', 'lowerLimit': '19.8', 'upperLimit': '25.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. t1/2,z was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of the investigational product and had at least 1 PK sample collected. Participants were included for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information is missing. Participants with data available at each timepoint are presented.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response According to Revised International Working Group (IWG) Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'OG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'OG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'classes': [{'categories': [{'title': 'CR', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}, {'title': 'CRi', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}, {'title': 'CRh', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}, {'title': 'Morphologic leukemia-free state', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}, {'title': 'Partial remission', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}, {'title': 'Treatment failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}, {'title': 'No evaluable response', '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'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Cycle 1 to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months', 'description': 'A response consisted of any of the following, assessed according to the IWG response criteria:\n\n* complete remission (CR): bone marrow (BM) blasts \\<5%; no blasts with Auer rods; no extramedullary disease; absolute neutrophil count \\>1.0 x 10\\^9/L; platelet count \\> 100 x 10\\^9/L; independence of red cell transfusions\n* CR with incomplete recovery of peripheral blood counts (CRi): CR except for residual neutropenia (\\< 1.0 x 10\\^9/L) or thrombocytopenia (\\< 100 x 10\\^9/L)\n* complete response/remission with partial hematologic recovery (CRh): ≤5% BM blasts, no circulating blasts/extramedullary disease and partial recovery of peripheral blood counts (platelets \\> 50,000/µL, hemoglobin ≥7g/dL and absolute neutrophil count \\> 500/µL).\n* morphologic leukemia-free state: BM blasts \\< 5%; no blasts with Auer rods; no extramedullary disease; no hematologic recovery required\n* partial remission: hematological criteria of CR; decrease BM blast to 5-25%; decrease of pretreatment BM blast percentage by ≤ 50%', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For Cohorts 1-15, the safety analysis set included all participants who received at least 1 dose of emirodatamab. For cohorts 16 and 17, the safety analysis set included all participants who received at least 1 dose of emirodatamab or etanercept.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an intravenous (IV) infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'FG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg subcutaneously (SC) 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'FG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '7'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '4'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '5'}, {'groupId': 'FG017', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Decision by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '4'}, {'groupId': 'FG017', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 11 study centers in 5 countries, including Australia, Canada, Germany, Japan, and the United States, and participated from 14 September 2018 to 21 February 2023.', 'preAssignmentDetails': 'Participants were enrolled into first-in-human (FIH) groups with no step dosing (cohorts 1 - 7a), and with step dosing (cohorts 7b - 13), into extended intravenous (eIV) groups (cohorts 14 -15), and into an etanercept substudy (cohorts 16 - 17). Dosing was from Dose A (lowest) to Dose M (highest).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '64', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 (FIH): Emirodatamab Dose A', 'description': 'Emirodatamab Dose A was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG001', 'title': 'Cohort 2 (FIH): Emirodatamab Dose B', 'description': 'Emirodatamab Dose B was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG002', 'title': 'Cohort 3 (FIH): Emirodatamab Dose C', 'description': 'Emirodatamab Dose C was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG003', 'title': 'Cohort 4 (FIH): Emirodatamab Dose D', 'description': 'Emirodatamab Dose D was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG004', 'title': 'Cohort 5 (FIH): Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG005', 'title': 'Cohort 6 (FIH): Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG006', 'title': 'Cohort 7a (FIH): Emirodatamab Dose G', 'description': 'Emirodatamab Dose G was administered as an IV infusion in a 2-week cycle with no step dosing. Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG007', 'title': 'Cohort 7b (FIH): Emirodatamab Dose F/Dose G', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose G (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG008', 'title': 'Cohort 8 (FIH): Emirodatamab Dose F/Dose H', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Dose H (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG009', 'title': 'Cohort 9 (FIH): Emirodatamab Dose F/Dose H/Dose I', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and I (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG010', 'title': 'Cohort 10 (FIH): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG011', 'title': 'Cohort 11 (FIH): Emirodatamab Dose F/Dose H/Dose K', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG012', 'title': 'Cohort 12 (FIH): Emirodatamab Dose F/Dose H/Dose L', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and L (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG013', 'title': 'Cohort 13 (FIH): Emirodatamab Dose F/Dose H/Dose M', 'description': 'Emirodatamab was administered as an IV infusion with step dosing; Dose F followed by Doses H and M (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG014', 'title': 'Cohort 14 (eIV): Emirodatamab Dose F/Dose H/Dose J/Dose K', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H, J, and K (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG015', 'title': 'Cohort 15 (eIV): Emirodatamab Dose F/Dose H/Dose J', 'description': 'Emirodatamab was administered as an eIV infusion with step dosing; Dose F followed by Doses H and J (2-week cycle). Dexamethasone 8 mg IV was administered within 1 hour before dosing.'}, {'id': 'BG016', 'title': 'Cohort 16: Etanercept + Emirodatamab Dose E', 'description': 'Emirodatamab Dose E was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'BG017', 'title': 'Cohort 17: Etanercept + Emirodatamab Dose F', 'description': 'Emirodatamab Dose F was administered as an IV infusion in a 2-week cycle. Participants were administered etanercept 50 mg SC 2 days before emirodatamab dosing. Dexamethasone 8 mg IV was administered within 1 hour before emirodatamab dosing.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 - 64 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '43', 'groupId': 'BG018'}]}, {'title': '65 - 74 years', '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': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '18', 'groupId': 'BG018'}]}, {'title': '75 - 84 years', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}]}, {'title': '≥ 85 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], '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': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '27', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '37', 'groupId': 'BG018'}]}]}], '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': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '5', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '56', 'groupId': 'BG018'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}]}, {'title': 'Black or African American', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '5', 'groupId': 'BG018'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '45', 'groupId': 'BG018'}]}, {'title': 'Other', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 2545416, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-15T10:23', 'hasProtocol': True}, {'date': '2022-04-25', 'size': 964559, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-02T13:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Premature discontinuation of study, a strategic decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2018-05-18', 'resultsFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-15', 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)', 'timeFrame': 'Days 1 to 28 for each cohort (28 days)', 'description': 'A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 except for cytokine release syndrome (CRS) grading:\n\n* drug-induced liver injury\n* any treatment-related death\n* Grade 2 CRS not resolving to ≤ grade 1 within 7 days; grade 3 CRS not resolving to ≤ grade 1 within 7 days; grade 3 CRS reported at the initial run-in dose; 2 separate grade 3 CRS events\n* Grade 4 CRS/infusion reactions\n* Grade 3-5 non-hematologic toxicity not clearly resulting from underlying leukemia except: alopecia, grade 3 rash, fatigue, asthenia, fever, anorexia, or constipation, nausea, vomiting or diarrhea not requiring tube feeding, total parenteral nutrition, or requiring/prolonging hospitalization; infection, bleeding, or other expected complication of cytopenias due to underlying leukemia; grade 3 infusion reaction including CRS; grade 3 tumor lysis syndrome\n* Grade 4 neutropenia persisting beyond 42 days in absence of leukemia.'}, {'measure': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs', 'timeFrame': 'Day 1 Cycle 1 to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.\n\nA TEAE was an AE that started on or after the first dose of investigational product (emirodatamab) up to 30 days after the end of investigational product or end of study date, whichever was earlier.\n\nA treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (emirodatamab).'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: Cycle 1 Day 5 (C1D5); Cohorts 14 and 15: Cycle 1 Day 8 (C1D8) (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.'}, {'measure': 'Time to Reach Cmax (Tmax) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.'}, {'measure': 'Minimum Concentration (Cmin) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis.'}, {'measure': 'Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. AUC(0-last) was calculated using the linear trapezoidal method.'}, {'measure': 'AUC From Time 0 to Infinity (AUC0-inf) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. The AUC(0-inf) was calculated using the linear trapezoidal method.'}, {'measure': 'AUC From Time Zero to 14 Days Post-dose (AUC14d) of Emirodatamab', 'timeFrame': 'For all cohorts: from time zero to 14-days following the C1D1 dose (1 cycle= 14 days)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. AUC(14d) was calculated as the sum of AUC values of all dosing days in cycle 1.'}, {'measure': 'Terminal Half-life (t1/2,z) of Emirodatamab', 'timeFrame': 'Cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: C1D5; Cohorts 14 and 15: C1D8 (sampling pre-dose up to 72 hours post-dose)', 'description': 'Serum concentrations of emirodatamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.05 ng/mL) were set to zero before data analysis. t1/2,z was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.'}, {'measure': 'Best Overall Response According to Revised International Working Group (IWG) Response Criteria', 'timeFrame': 'Day 1 Cycle 1 to 30 days after last dose of investigational product or end of study; median treatment duration was 0.62 months', 'description': 'A response consisted of any of the following, assessed according to the IWG response criteria:\n\n* complete remission (CR): bone marrow (BM) blasts \\<5%; no blasts with Auer rods; no extramedullary disease; absolute neutrophil count \\>1.0 x 10\\^9/L; platelet count \\> 100 x 10\\^9/L; independence of red cell transfusions\n* CR with incomplete recovery of peripheral blood counts (CRi): CR except for residual neutropenia (\\< 1.0 x 10\\^9/L) or thrombocytopenia (\\< 100 x 10\\^9/L)\n* complete response/remission with partial hematologic recovery (CRh): ≤5% BM blasts, no circulating blasts/extramedullary disease and partial recovery of peripheral blood counts (platelets \\> 50,000/µL, hemoglobin ≥7g/dL and absolute neutrophil count \\> 500/µL).\n* morphologic leukemia-free state: BM blasts \\< 5%; no blasts with Auer rods; no extramedullary disease; no hematologic recovery required\n* partial remission: hematological criteria of CR; decrease BM blast to 5-25%; decrease of pretreatment BM blast percentage by ≤ 50%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Acute Myeloid Leukemia (AML)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose \\[RP2D\\]).', 'detailedDescription': 'Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose \\[RP2D\\]). Approximately 80 subjects will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.\n* Subjects greater than or equal to 18 years of age at the time of signing consent.\n* For relapsed/refractory AML subjects only, AML as defined by the WHO Classification as persisting or recurring following 1 or more treatment courses (exceptions noted in exclusion criteria).\n* Myeloblasts greater than or equal to 5% in bone marrow, as confirmed by immunophenotype by flow cytometry.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.\n* Renal function as follows: serum creatinine less than 2.0 mg/dL (176.84 µmol/L); estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m\\^2.\n* Hepatic function as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 x upper limit of normal (ULN); bilirubin less than or equal to 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis).\n* No active tuberculosis in the setting of anti-tumor necrosis factor (TNF) therapy - National guidelines should be followed for the appropriate tuberculosis screening in the setting of anti-TNF therapy, including a minimum of:\n\n * Subject has a negative test for tuberculosis during screening defined as either:\n\n * Negative purified protein derivative (PPD) (\\< 5 mm induration at 48 to 72 hours after test is placed) OR\n * Negative Quantiferon test\n * Subjects with positive PPD and a history of bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test.\n * Subjects with a positive PPD test (without a history of bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:\n\n * No symptoms, per tuberculosis worksheet provided by Amgen\n * Documented history of a completed course of adequate treatment or prophylaxis (per local standard of care) prior to the start of investigational product\n * No known exposure to a case of active tuberculosis after most recent prophylaxis\n * No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product (substudy subjects only)\n\nExclusion Criteria:\n\n* Patients with acute promyelocytic leukemia (APML).\n* Active extramedullary AML in the central nervous system (CNS)\n* Known hypersensitivity to immunoglobulins.\n* White blood cells (WBC) greater than 15,000 cells/mcL (15 cells x 10\\^9/L) at screening (hydroxyurea is permitted to enable eligibility).\n* Subjects with a prior or concurrent malignancy whose natural history or treatment is anticipated to interfere with the safety or efficacy assessment of the investigational regimen. Exception: Subjects with prior or concurrent malignancy not anticipated to interfere with the safety or efficacy of the investigational regimen may be included only after discussion with the Amgen Medical Monitor.\n* Autologous hematopoietic stem cell transplant (HSCT) within 6 weeks prior to start of AMG 427 treatment.\n* Allogeneic HSCT within 3 months prior to start of AMG 427 treatment.\n* Any graft-versus-host disease requiring systemic therapy with immunomodulators.\n* History or evidence of significant cardiovascular risk including any of the following: symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias (eg, ventricular fibrillation, ventricular tachycardia etc.), recent coronary angioplasty, intra-cardiac defibrillators or any clinically relevant concurrent disorder that may pose a risk to subject safety or interfere with study evaluation, procedures, or completion.\n* History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months.\n* Active infection requiring intravenous antibiotics within 1 week of study enrollment (day 1). Antibiotics may be administered for prophylaxis as per institutional standards up to and after enrollment.\n* Known positive test for human immunodeficiency virus (HIV).\n* Positive for hepatitis B surface antigen (HepBsAg).\n* Positive for hepatitis C or chronic hepatitis C. Possible exceptions: acute hepatitis C and completely cleared of the virus (demonstrated by negative viral load), chronic hepatitis C with undetectable viral load defined by sustained virologic response 24 weeks (SVR24) after completion of anti-hepatitis C treatment.\n* Live vaccination(s) within 4 weeks before the start of AMG 427 treatment on day 1, during treatment, and until the end of the last study dose.\n* Unresolved toxicities from prior antitumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for greater than 2 months) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor.\n* Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or investigational agent) within 14 days of day 1. Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of investigational product treatment. Exception: antitumor therapies with short half-lives only require passing of 5 half-lives from last dose, and after discussion with sponsor.\n* Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment (day 1). Exceptions: physiologic replacement steroids or steroids for treatment of transfusion/hypersensitivity reactions.\n* Prior treatment with a fms-like tyrosine kinase 3 (FLT3) targeting chimeric antigen receptor T cell (CAR-T)\n* Major surgery within 28 days of study day 1 with the exception of biopsy and insertion of central venous catheter.\n* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n* Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women).\n* Females who are lactating/breastfeeding or who plan to breastfeed while on study through 4 weeks after receiving the last dose of study drug.\n* Females with a positive pregnancy test.\n* Females planning to become pregnant while on study through 4 weeks after receiving the last dose of study drug.\n* Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.\n* History of multiple sclerosis or any other demyelinating disease.\n* No active hepatitis secondary to alcoholic hepatitis or nonalcoholic steatohepatitis.\n* History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with Medical Monitor and meeting the following criteria:\n\n * Negative test for SARS-CoV-2 RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) within 72 hours of first dose of investigational product\n * No acute symptoms of coronavirus disease 2019 (COVID-19) disease within 10 days prior to first dose of investigational product (counted from day of positive test for asymptomatic subjects)"}, 'identificationModule': {'nctId': 'NCT03541369', 'acronym': '20170528', 'briefTitle': 'Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.', 'orgStudyIdInfo': {'id': '20170528'}, 'secondaryIdInfos': [{'id': 'BB-IND 138440', 'type': 'OTHER_GRANT', 'domain': 'IND Number'}, {'id': '2018-001389-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Phase', 'description': 'AMG 427 Dose-finding phase of the study', 'interventionNames': ['Drug: AMG 427']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Phase', 'description': 'AMG 427 MTD identified in dose escalation phase (or lower) will be administered to subjects.', 'interventionNames': ['Drug: AMG 427']}], 'interventions': [{'name': 'AMG 427', 'type': 'DRUG', 'otherNames': ['AMG 427; 20170528'], 'description': 'AMG 427 will be administered as an intravenous (IV) infusion in adult subjects with relapsed/refractory AML.', 'armGroupLabels': ['Dose Escalation Phase', 'Dose Expansion Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network-Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universitaet Muenchen Campus Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'zip': '910-1193', 'city': 'Yoshida-gun', 'state': 'Fukui', 'country': 'Japan', 'facility': 'University of Fukui Hospital'}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}