Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-03-10 @ 7:23 PM
Study NCT ID:
NCT02432235
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2015-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002147', 'term': 'Calmodulin'}], 'ancestors': [{'id': 'D052139', 'term': 'Intracellular Calcium-Sensing Proteins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002135', 'term': 'Calcium-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@adctherapeutics.com', 'phone': '954-903-7994', 'title': 'Clinical Trials Information', 'phoneExt': '954', 'organization': 'ADC Therapeutics SA'}, 'certainAgreement': {'otherDetails': "PI can publish after first multi-site publication or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on PI is sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period \\>60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \\[min 1 day; max 354 days\\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \\[min 1 day; max 354 days\\]).', 'eventGroups': [{'id': 'EG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 3, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'deathsNumAffected': 11, 'seriousNumAffected': 24}, {'id': 'EG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'deathsNumAffected': 15, 'seriousNumAffected': 14}, {'id': 'EG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'deathsNumAffected': 15, 'seriousNumAffected': 18}, {'id': 'EG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry 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{'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)', 'description': 'A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes:\n\nA hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants):\n\n* Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection\n* CTCAE Grade 4 neutropenia lasting \\>7 days\n* CTCAE Grade 4 thrombocytopenia\n* CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion\n* CTCAE Grade 4 anemia\n\nA non-hematologic DLT is defined as:\n\n* CTCAE Grade 4 tumor lysis syndrome\n* CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia)\n* CTCAE Grade 3 or higher hypersensitivity reaction\n* CTCAE Grade 2 or higher skin ulceration\n* CTCAE Grade 2 or higher peripheral sensory or motor neuropathy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.'}, {'type': 'PRIMARY', 'title': 'Recommended Dose of Camidanlumab Tesirine for Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-Limiting Toxicity (DLT) Evaluable Set Analysis Set', 'description': 'DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.'}], 'classes': [{'title': 'Participants with Hodgkin Lymphoma (Dose level 1: 30 µg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Hodgkin Lymphoma (Dose level 2: 45 µg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Participants with T-cell Lymphoma (80 µg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)', 'description': 'The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.', 'unitOfMeasure': 'μg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed presented in the outcome measure data are only those participants in the DLT evaluable analysis set who were dosed at the three dose levels recommended for Part 2.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after treatment; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'ORR is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine.\n\nTumor response was assessed using the 2014 Lugano Classification.\n\nCR is defined as achieving each of the following:\n\n* Complete metabolic response.\n* Complete radiologic response (target node regress to \\<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).\n\nPR is defined as achieving each of the following:\n\n* Partial metabolic response (findings indicate residual disease).\n* Partial remission (\\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \\>50% in length and no new lesions).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy Analysis Set', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '7.23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'DoR is defined among responders (complete response \\[CR\\] and partial response \\[PR\\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification.\n\nDisease progression is defined as progressive metabolic disease and one of the follow:\n\n* Target node progression.\n* An individual extranodal lesion must be abnormal with length \\> 1.5cm and/or increase of length \\> 50%.\n* New or clear progression of nonmeasured lesions.\n* Regrowth of previously resolved lesions or new nodes \\>1.5 cm in length.\n* New or recurrent bone marrow involvement.\n\nDoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy Analysis Set', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.22', 'groupId': 'OG000', 'lowerLimit': '3.78', 'upperLimit': '5.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.\n\nDisease progression is defined as progressive metabolic disease and one of the following:\n\n* Target node progression.\n* An individual extranodal lesion must be abnormal with length \\> 1.5cm and/or increase of length \\> 50%.\n* New or clear progression of nonmeasured lesions.\n* Regrowth of previously resolved lesions or new nodes \\> 1.5 cm in length.\n* New or recurrent bone marrow involvement.\n\nPFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy Analysis Set', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.26', 'comment': 'Insufficient number of participants died during the study, so confidence upper limit could not be calculated.', 'groupId': 'OG000', 'lowerLimit': '10.02', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause.\n\nOS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': '131', 'spread': '20.7', 'groupId': 'OG002'}, {'value': '189', 'spread': '98.4', 'groupId': 'OG003'}, {'value': '318', 'spread': '82.9', 'groupId': 'OG004'}, {'value': '603', 'spread': '31.8', 'groupId': 'OG005'}, {'value': '803', 'spread': '54.4', 'groupId': 'OG006'}, {'value': '1120', 'spread': '82.8', 'groupId': 'OG007'}, {'value': '1325', 'spread': '43.1', 'groupId': 'OG008'}, {'value': '1494', 'spread': '26.1', 'groupId': 'OG009'}, {'value': '2671', 'spread': '32.9', 'groupId': 'OG010'}, {'value': '5020', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '177', 'spread': '39.4', 'groupId': 'OG002'}, {'value': '254', 'spread': '13.1', 'groupId': 'OG003'}, {'value': '224', 'groupId': 'OG004'}, {'value': '554', 'spread': '48.1', 'groupId': 'OG005'}, {'value': '1040', 'spread': '60.0', 'groupId': 'OG006'}, {'value': '1402', 'spread': '56.1', 'groupId': 'OG007'}, {'value': '1379', 'spread': '32.2', 'groupId': 'OG008'}, {'value': '800', 'spread': '726', 'groupId': 'OG009'}, {'value': '3251', 'spread': '37.8', 'groupId': 'OG010'}, {'value': '497', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}, {'value': '127', 'spread': '27.6', 'groupId': 'OG002'}, {'value': '152', 'spread': '95.1', 'groupId': 'OG003'}, {'value': '241', 'spread': '76.7', 'groupId': 'OG004'}, {'value': '455', 'spread': '38.5', 'groupId': 'OG005'}, {'value': '648', 'spread': '51.0', 'groupId': 'OG006'}, {'value': '881', 'spread': '78.8', 'groupId': 'OG007'}, {'value': '1055', 'spread': '45.9', 'groupId': 'OG008'}, {'value': '1154', 'spread': '26.4', 'groupId': 'OG009'}, {'value': '2097', 'spread': '21.1', 'groupId': 'OG010'}, {'value': '4020', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '151', 'spread': '23.2', 'groupId': 'OG002'}, {'value': '208', 'spread': '18.4', 'groupId': 'OG003'}, {'value': '164', 'groupId': 'OG004'}, {'value': '424', 'spread': '47.8', 'groupId': 'OG005'}, {'value': '808', 'spread': '55.8', 'groupId': 'OG006'}, {'value': '1084', 'spread': '59.9', 'groupId': 'OG007'}, {'value': '1084', 'spread': '32.0', 'groupId': 'OG008'}, {'value': '645', 'spread': '655', 'groupId': 'OG009'}, {'value': '2090', 'spread': '31.6', 'groupId': 'OG010'}, {'value': '497', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - Free warhead (SG3199)', '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': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0120', 'spread': '8.04', 'groupId': 'OG006'}, {'value': '0.0310', 'spread': '102', 'groupId': 'OG007'}, {'value': '0.0150', 'spread': '34.6', 'groupId': 'OG008'}, {'value': '0.0110', 'groupId': 'OG009'}, {'value': '0.0170', 'groupId': 'OG010'}, {'value': '0.0240', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0170', 'spread': '46.9', 'groupId': 'OG006'}, {'value': '0.132', 'spread': '413', 'groupId': 'OG007'}, {'value': '0.0140', 'spread': '4.21', 'groupId': 'OG008'}, {'value': '0.0270', 'groupId': 'OG009'}, {'value': '0.0170', 'spread': '20.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.155', 'groupId': 'OG000'}, {'value': '0.0830', 'groupId': 'OG001'}, {'value': '0.0970', 'spread': '22.4', 'groupId': 'OG002'}, {'value': '0.149', 'spread': '75.3', 'groupId': 'OG003'}, {'value': '0.103', 'spread': '26.4', 'groupId': 'OG004'}, {'value': '0.0820', 'spread': '38.5', 'groupId': 'OG005'}, {'value': '0.0950', 'spread': '67.5', 'groupId': 'OG006'}, {'value': '0.106', 'spread': '58.3', 'groupId': 'OG007'}, {'value': '0.105', 'spread': '45.1', 'groupId': 'OG008'}, {'value': '0.111', 'spread': '22.3', 'groupId': 'OG009'}, {'value': '0.157', 'spread': '0.937', 'groupId': 'OG010'}, {'value': '0.172', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.149', 'groupId': 'OG000'}, {'value': '0.110', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '0.137', 'spread': '69.8', 'groupId': 'OG003'}, {'value': '0.130', 'groupId': 'OG004'}, {'value': '0.0640', 'spread': '105', 'groupId': 'OG005'}, {'value': '0.0790', 'spread': '81.6', 'groupId': 'OG006'}, {'value': '0.0910', 'spread': '100', 'groupId': 'OG007'}, {'value': '0.0830', 'spread': '71.7', 'groupId': 'OG008'}, {'value': '0.0700', 'spread': '31.4', 'groupId': 'OG009'}, {'value': '0.145', 'spread': '21.1', 'groupId': 'OG010'}, {'value': '0.0310', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.155', 'groupId': 'OG000'}, {'value': '0.114', 'spread': '46.4', 'groupId': 'OG002'}, {'value': '0.110', 'spread': '24.6', 'groupId': 'OG003'}, {'value': '0.131', 'spread': '64.3', 'groupId': 'OG004'}, {'value': '0.0910', 'spread': '47.1', 'groupId': 'OG005'}, {'value': '0.0950', 'spread': '62.4', 'groupId': 'OG006'}, {'value': '0.0970', 'spread': '44.6', 'groupId': 'OG007'}, {'value': '0.118', 'spread': '83.0', 'groupId': 'OG008'}, {'value': '0.111', 'spread': '22.3', 'groupId': 'OG009'}, {'value': '0.114', 'spread': '46.7', 'groupId': 'OG010'}, {'value': '0.0830', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.336', 'groupId': 'OG000'}, {'value': '0.126', 'spread': '37.9', 'groupId': 'OG002'}, {'value': '0.0860', 'spread': '1.70', 'groupId': 'OG003'}, {'value': '0.0920', 'groupId': 'OG004'}, {'value': '0.0640', 'spread': '121', 'groupId': 'OG005'}, {'value': '0.0660', 'spread': '64.3', 'groupId': 'OG006'}, {'value': '0.0690', 'spread': '110', 'groupId': 'OG007'}, {'value': '0.0720', 'spread': '79.3', 'groupId': 'OG008'}, {'value': '0.0850', 'spread': '2.89', 'groupId': 'OG009'}, {'value': '0.0940', 'spread': '160', 'groupId': 'OG010'}, {'value': '0.0310', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - Free warhead (SG3199)', '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': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.119', 'spread': '75.0', 'groupId': 'OG006'}, {'value': '0.124', 'spread': '83.6', 'groupId': 'OG007'}, {'value': '0.206', 'spread': '69.8', 'groupId': 'OG008'}, {'value': '0.211', 'groupId': 'OG009'}, {'value': '0.240', 'groupId': 'OG010'}, {'value': '0.172', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.192', 'spread': '42.6', 'groupId': 'OG006'}, {'value': '0.0970', 'spread': '119', 'groupId': 'OG007'}, {'value': '0.201', 'spread': '24.8', 'groupId': 'OG008'}, {'value': '0.167', 'groupId': 'OG009'}, {'value': '0.156', 'spread': '109', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'Days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000'}, {'value': '2.60', 'groupId': 'OG001'}, {'value': '48.2', 'spread': '207', 'groupId': 'OG002'}, {'value': '76.3', 'spread': '1444', 'groupId': 'OG003'}, {'value': '660', 'spread': '93.7', 'groupId': 'OG004'}, {'value': '967', 'spread': '60.4', 'groupId': 'OG005'}, {'value': '1715', 'spread': '128', 'groupId': 'OG006'}, {'value': '2491', 'spread': '132', 'groupId': 'OG007'}, {'value': '2751', 'spread': '109', 'groupId': 'OG008'}, {'value': '4091', 'spread': '84.6', 'groupId': 'OG009'}, {'value': '12919', 'spread': '14.6', 'groupId': 'OG010'}, {'value': '30759', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '111', 'spread': '35.0', 'groupId': 'OG002'}, {'value': '453', 'spread': '35.3', 'groupId': 'OG003'}, {'value': '473', 'groupId': 'OG004'}, {'value': '1004', 'spread': '66.8', 'groupId': 'OG005'}, {'value': '2476', 'spread': '117', 'groupId': 'OG006'}, {'value': '3665', 'spread': '127', 'groupId': 'OG007'}, {'value': '4190', 'spread': '123', 'groupId': 'OG008'}, {'value': '921', 'spread': '1700356', 'groupId': 'OG009'}, {'value': '12767', 'spread': '13.1', 'groupId': 'OG010'}, {'value': '919', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '458', 'groupId': 'OG002'}, {'value': '76.8', 'spread': '470', 'groupId': 'OG003'}, {'value': '262', 'spread': '276', 'groupId': 'OG004'}, {'value': '625', 'spread': '53.1', 'groupId': 'OG005'}, {'value': '1173', 'spread': '113', 'groupId': 'OG006'}, {'value': '1623', 'spread': '102', 'groupId': 'OG007'}, {'value': '1630', 'spread': '155', 'groupId': 'OG008'}, {'value': '2849', 'spread': '68.0', 'groupId': 'OG009'}, {'value': '7727', 'spread': '11.2', 'groupId': 'OG010'}, {'value': '18915', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '15.9', 'groupId': 'OG002'}, {'value': '237', 'spread': '23.1', 'groupId': 'OG003'}, {'value': '330', 'groupId': 'OG004'}, {'value': '655', 'spread': '53.3', 'groupId': 'OG005'}, {'value': '1514', 'spread': '103', 'groupId': 'OG006'}, {'value': '2283', 'spread': '94.5', 'groupId': 'OG007'}, {'value': '3038', 'spread': '97.7', 'groupId': 'OG008'}, {'value': '1482', 'spread': '13082', 'groupId': 'OG009'}, {'value': '8992', 'spread': '28.3', 'groupId': 'OG010'}, {'value': '634', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - Free warhead (SG3199)', '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': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.00200', 'spread': '331', 'groupId': 'OG006'}, {'value': '0.00200', 'spread': '127', 'groupId': 'OG007'}, {'value': '0.00300', 'spread': '290', 'groupId': 'OG008'}, {'value': '0.0100', 'groupId': 'OG009'}, {'value': '0.00400', 'groupId': 'OG010'}, {'value': '0.0360', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.00300', 'spread': '74.6', 'groupId': 'OG006'}, {'value': '0.0330', 'spread': '183', 'groupId': 'OG007'}, {'value': '0.00600', 'spread': '79.8', 'groupId': 'OG008'}, {'value': '0.00300', 'groupId': 'OG009'}, {'value': '0.0130', 'spread': '5.60', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '195', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '596', 'spread': '25.9', 'groupId': 'OG003'}, {'value': '747', 'groupId': 'OG004'}, {'value': '1384', 'spread': '62.6', 'groupId': 'OG005'}, {'value': '3604', 'spread': '68.9', 'groupId': 'OG006'}, {'value': '4688', 'spread': '98.3', 'groupId': 'OG007'}, {'value': '5689', 'spread': '58.2', 'groupId': 'OG008'}, {'value': '18830', 'groupId': 'OG009'}, {'value': '17031', 'spread': '45.1', 'groupId': 'OG010'}, {'value': '1074', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG002'}, {'value': '385', 'spread': '28.5', 'groupId': 'OG003'}, {'value': '489', 'groupId': 'OG004'}, {'value': '939', 'spread': '53.6', 'groupId': 'OG005'}, {'value': '2183', 'spread': '61.6', 'groupId': 'OG006'}, {'value': '2811', 'spread': '76.7', 'groupId': 'OG007'}, {'value': '3469', 'spread': '91.3', 'groupId': 'OG008'}, {'value': '1809', 'spread': '4154', 'groupId': 'OG009'}, {'value': '9851', 'spread': '28.3', 'groupId': 'OG010'}, {'value': '763', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0310', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)', 'description': 'AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.', 'unitOfMeasure': 'day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', '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': '14', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1283', 'spread': '63.1', 'groupId': 'OG005'}, {'value': '3001', 'spread': '75.0', 'groupId': 'OG006'}, {'value': '3618', 'spread': '52.9', 'groupId': 'OG007'}, {'value': '3261', 'spread': '83.9', 'groupId': 'OG008'}, {'value': '4972', 'spread': '116', 'groupId': 'OG009'}, {'value': '13842', 'spread': '9.45', 'groupId': 'OG010'}, {'value': '33153', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '917', 'groupId': 'OG004'}, {'value': '1019', 'spread': '54.9', 'groupId': 'OG005'}, {'value': '1846', 'spread': '59.9', 'groupId': 'OG006'}, {'value': '2284', 'spread': '50.8', 'groupId': 'OG007'}, {'value': '2797', 'spread': '81.7', 'groupId': 'OG008'}, {'value': '3734', 'spread': '82.7', 'groupId': 'OG009'}, {'value': '8730', 'spread': '5.31', 'groupId': 'OG010'}, {'value': '20144', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)', 'description': 'AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.', 'unitOfMeasure': 'day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Accumulation Index (AI) for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.0000132', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '0.000584', 'groupId': 'OG003'}, {'value': '1.00', 'groupId': 'OG004'}, {'value': '1.01', 'spread': '3.41', 'groupId': 'OG005'}, {'value': '1.02', 'spread': '2.59', 'groupId': 'OG006'}, {'value': '1.03', 'spread': '4.24', 'groupId': 'OG007'}, {'value': '1.04', 'spread': '3.48', 'groupId': 'OG008'}, {'value': '1.23', 'groupId': 'OG009'}, {'value': '1.08', 'spread': '6.58', 'groupId': 'OG010'}, {'value': '1.00', 'groupId': 'OG011'}]}]}, {'title': 'PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '0.00153', 'groupId': 'OG003'}, {'value': '1.00', 'groupId': 'OG004'}, {'value': '1.00', 'spread': '0.234', 'groupId': 'OG005'}, {'value': '1.01', 'spread': '1.48', 'groupId': 'OG006'}, {'value': '1.03', 'spread': '4.94', 'groupId': 'OG007'}, {'value': '1.03', 'spread': '2.38', 'groupId': 'OG008'}, {'value': '1.06', 'spread': '8.36', 'groupId': 'OG009'}, {'value': '1.06', 'spread': '0.381', 'groupId': 'OG010'}, {'value': '1.00', 'groupId': 'OG011'}]}]}, {'title': 'Free warhead (SG3199)', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution for Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', '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': '14', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3.93', 'spread': '43.2', 'groupId': 'OG005'}, {'value': '4.57', 'spread': '26.9', 'groupId': 'OG006'}, {'value': '4.55', 'spread': '27.0', 'groupId': 'OG007'}, {'value': '4.28', 'spread': '159', 'groupId': 'OG008'}, {'value': '6.11', 'spread': '8.73', 'groupId': 'OG009'}, {'value': '7.01', 'spread': '46.4', 'groupId': 'OG010'}, {'value': '4.84', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3.71', 'spread': '70.3', 'groupId': 'OG002'}, {'value': '3.26', 'spread': '19.9', 'groupId': 'OG003'}, {'value': '7.72', 'groupId': 'OG004'}, {'value': '4.28', 'spread': '60.1', 'groupId': 'OG005'}, {'value': '4.54', 'spread': '36.0', 'groupId': 'OG006'}, {'value': '4.64', 'spread': '26.5', 'groupId': 'OG007'}, {'value': '5.23', 'spread': '24.8', 'groupId': 'OG008'}, {'value': '5.55', 'groupId': 'OG009'}, {'value': '6.13', 'spread': '6.58', 'groupId': 'OG010'}, {'value': '2.44', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG004'}, {'value': '3.28', 'spread': '56.7', 'groupId': 'OG005'}, {'value': '5.08', 'spread': '23.3', 'groupId': 'OG006'}, {'value': '5.05', 'spread': '25.5', 'groupId': 'OG007'}, {'value': '5.15', 'spread': '34.5', 'groupId': 'OG008'}, {'value': '6.91', 'spread': '14.4', 'groupId': 'OG009'}, {'value': '9.03', 'spread': '71.7', 'groupId': 'OG010'}, {'value': '5.84', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5.89', 'groupId': 'OG002'}, {'value': '3.56', 'spread': '14.7', 'groupId': 'OG003'}, {'value': '8.39', 'groupId': 'OG004'}, {'value': '4.81', 'spread': '53.0', 'groupId': 'OG005'}, {'value': '4.91', 'spread': '29.9', 'groupId': 'OG006'}, {'value': '5.10', 'spread': '30.2', 'groupId': 'OG007'}, {'value': '5.89', 'spread': '25.7', 'groupId': 'OG008'}, {'value': '14.5', 'spread': '257', 'groupId': 'OG009'}, {'value': '7.55', 'spread': '8.86', 'groupId': 'OG010'}, {'value': '2.90', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '7246', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', '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': '14', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '58.9', 'groupId': 'OG005'}, {'value': '2.62', 'spread': '44.1', 'groupId': 'OG006'}, {'value': '2.76', 'spread': '51.9', 'groupId': 'OG007'}, {'value': '1.98', 'spread': '78.1', 'groupId': 'OG008'}, {'value': '2.49', 'spread': '131', 'groupId': 'OG009'}, {'value': '4.42', 'spread': '0.622', 'groupId': 'OG010'}, {'value': '7.68', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.835', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '1.63', 'spread': '0.507', 'groupId': 'OG003'}, {'value': '2.61', 'groupId': 'OG004'}, {'value': '1.87', 'spread': '50.7', 'groupId': 'OG005'}, {'value': '3.26', 'spread': '38.0', 'groupId': 'OG006'}, {'value': '3.26', 'spread': '59.5', 'groupId': 'OG007'}, {'value': '3.65', 'spread': '42.4', 'groupId': 'OG008'}, {'value': '8.74', 'groupId': 'OG009'}, {'value': '5.38', 'spread': '34.4', 'groupId': 'OG010'}, {'value': '1.43', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG004'}, {'value': '1.39', 'spread': '49.8', 'groupId': 'OG005'}, {'value': '2.31', 'spread': '45.5', 'groupId': 'OG006'}, {'value': '2.43', 'spread': '44.7', 'groupId': 'OG007'}, {'value': '2.11', 'spread': '78.6', 'groupId': 'OG008'}, {'value': '2.92', 'spread': '152', 'groupId': 'OG009'}, {'value': '5.59', 'spread': '50.9', 'groupId': 'OG010'}, {'value': '7.16', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '5.69', 'groupId': 'OG003'}, {'value': '2.24', 'groupId': 'OG004'}, {'value': '1.78', 'spread': '28.4', 'groupId': 'OG005'}, {'value': '2.69', 'spread': '40.2', 'groupId': 'OG006'}, {'value': '2.93', 'spread': '62.2', 'groupId': 'OG007'}, {'value': '3.06', 'spread': '67.2', 'groupId': 'OG008'}, {'value': '3.03', 'spread': '156', 'groupId': 'OG009'}, {'value': '5.02', 'spread': '2.26', 'groupId': 'OG010'}, {'value': '1.67', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'Days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Clearance of Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Cycle 1 - HuMax-TAC', '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': '14', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '69.0', 'groupId': 'OG005'}, {'value': '1.29', 'spread': '64.0', 'groupId': 'OG006'}, {'value': '1.24', 'spread': '54.5', 'groupId': 'OG007'}, {'value': '1.60', 'spread': '184', 'groupId': 'OG008'}, {'value': '1.82', 'spread': '136', 'groupId': 'OG009'}, {'value': '1.05', 'spread': '22.6', 'groupId': 'OG010'}, {'value': '0.489', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3.23', 'spread': '50.1', 'groupId': 'OG002'}, {'value': '1.44', 'spread': '22.5', 'groupId': 'OG003'}, {'value': '2.01', 'groupId': 'OG004'}, {'value': '1.60', 'spread': '66.5', 'groupId': 'OG005'}, {'value': '1.03', 'spread': '61.2', 'groupId': 'OG006'}, {'value': '0.950', 'spread': '85.9', 'groupId': 'OG007'}, {'value': '1.10', 'spread': '46.2', 'groupId': 'OG008'}, {'value': '0.446', 'groupId': 'OG009'}, {'value': '0.849', 'spread': '30.8', 'groupId': 'OG010'}, {'value': '1.23', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.943', 'groupId': 'OG004'}, {'value': '1.75', 'spread': '55.6', 'groupId': 'OG005'}, {'value': '1.68', 'spread': '50.3', 'groupId': 'OG006'}, {'value': '1.65', 'spread': '48.9', 'groupId': 'OG007'}, {'value': '1.87', 'spread': '99.0', 'groupId': 'OG008'}, {'value': '1.94', 'spread': '98.7', 'groupId': 'OG009'}, {'value': '1.33', 'spread': '18.4', 'groupId': 'OG010'}, {'value': '0.643', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - PBD-conjugated HuMax-TAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG002'}, {'value': '1.79', 'spread': '25.1', 'groupId': 'OG003'}, {'value': '2.46', 'groupId': 'OG004'}, {'value': '1.93', 'spread': '57.2', 'groupId': 'OG005'}, {'value': '1.37', 'spread': '55.3', 'groupId': 'OG006'}, {'value': '1.27', 'spread': '62.8', 'groupId': 'OG007'}, {'value': '1.44', 'spread': '86.9', 'groupId': 'OG008'}, {'value': '3.28', 'spread': '2602', 'groupId': 'OG009'}, {'value': '1.17', 'spread': '15.0', 'groupId': 'OG010'}, {'value': '1.38', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 2 - Free warhead (SG3199)', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '4302', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).', 'unitOfMeasure': 'Liters/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'OG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'classes': [{'title': 'Confirmed positive ADA pre-dose', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Confirmed positive ADA post-dose only', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Confirmed positive ADA at any time', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - The safety analysis set consisted of all participants who received camidanlumab tesirine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'FG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '41'}, {'groupId': 'FG007', 'numSubjects': '29'}, {'groupId': 'FG008', 'numSubjects': '26'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '23'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '21'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'There were 12 sites that screened and enrolled participants: USA: 7 sites; UK: 5 sites.', 'preAssignmentDetails': 'Participants were included in a screening period of up to 28 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG001', 'title': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG002', 'title': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG003', 'title': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG004', 'title': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG005', 'title': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG006', 'title': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG007', 'title': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG008', 'title': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG009', 'title': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG010', 'title': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG011', 'title': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).\n\nCamidanlumab tesirine: Intravenous (IV) infusion.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '73.5', 'spread': '2.12', 'groupId': 'BG000'}, {'value': '44.0', 'spread': '2.83', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '12.73', 'groupId': 'BG002'}, {'value': '51.0', 'spread': '12.53', 'groupId': 'BG003'}, {'value': '38.0', 'spread': '19.80', 'groupId': 'BG004'}, {'value': '42.1', 'spread': '16.32', 'groupId': 'BG005'}, {'value': '45.1', 'spread': '15.48', 'groupId': 'BG006'}, {'value': '56.3', 'spread': '18.16', 'groupId': 'BG007'}, {'value': '58.1', 'spread': '15.69', 'groupId': 'BG008'}, {'value': '58.7', 'spread': '8.08', 'groupId': 'BG009'}, {'value': '44.5', 'spread': '19.09', 'groupId': 'BG010'}, {'value': '64.0', 'groupId': 'BG011'}, {'value': '50.8', 'spread': '17.13', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '55', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '78', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '13', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '120', 'groupId': 'BG012'}]}, {'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': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '106', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '98', 'groupId': 'BG012'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'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': '14', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '35', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'Grade 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '43', 'groupId': 'BG012'}]}]}, {'title': 'Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '79', 'groupId': 'BG012'}]}]}, {'title': 'Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}]}]}, {'title': 'Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'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'}]}]}, {'title': 'Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'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'}]}]}, {'title': 'Grade 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG performance status was graded on a scale of 0-5, where a higher score indicated a worse outcome:\n\n0\\. = fully active\n\n1. = capable of light work of a sedentary nature\n2. = capable of self-care; unable to carry out work activities\n3. = capable of only limited self-care\n4. = completely disabled; cannot carry out any self-care\n5. = dead', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '133', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '98.05', 'spread': '26.517', 'groupId': 'BG000'}, {'value': '55.25', 'spread': '12.799', 'groupId': 'BG001'}, {'value': '80.40', 'spread': '19.658', 'groupId': 'BG002'}, {'value': '63.57', 'spread': '4.840', 'groupId': 'BG003'}, {'value': '65.05', 'spread': '14.496', 'groupId': 'BG004'}, {'value': '79.18', 'spread': '19.920', 'groupId': 'BG005'}, {'value': '89.10', 'spread': '31.926', 'groupId': 'BG006'}, {'value': '75.15', 'spread': '18.241', 'groupId': 'BG007'}, {'value': '78.19', 'spread': '15.780', 'groupId': 'BG008'}, {'value': '82.67', 'spread': '15.808', 'groupId': 'BG009'}, {'value': '96.50', 'spread': '12.869', 'groupId': 'BG010'}, {'value': '53.20', 'groupId': 'BG011'}, {'value': '80.69', 'spread': '23.766', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '129', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '176.65', 'spread': '24.961', 'groupId': 'BG000'}, {'value': '158.00', 'spread': '1.414', 'groupId': 'BG001'}, {'value': '176.00', 'spread': '4.243', 'groupId': 'BG002'}, {'value': '170.43', 'spread': '5.811', 'groupId': 'BG003'}, {'value': '170.20', 'groupId': 'BG004'}, {'value': '172.13', 'spread': '11.212', 'groupId': 'BG005'}, {'value': '172.12', 'spread': '9.410', 'groupId': 'BG006'}, {'value': '171.43', 'spread': '9.341', 'groupId': 'BG007'}, {'value': '170.33', 'spread': '10.188', 'groupId': 'BG008'}, {'value': '173.43', 'spread': '10.856', 'groupId': 'BG009'}, {'value': '172.50', 'spread': '13.435', 'groupId': 'BG010'}, {'value': '155.00', 'groupId': 'BG011'}, {'value': '171.37', 'spread': '9.920', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '129', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '33.60', 'spread': '17.816', 'groupId': 'BG000'}, {'value': '22.18', 'spread': '5.524', 'groupId': 'BG001'}, {'value': '25.83', 'spread': '5.100', 'groupId': 'BG002'}, {'value': '21.98', 'spread': '2.829', 'groupId': 'BG003'}, {'value': '25.99', 'groupId': 'BG004'}, {'value': '26.69', 'spread': '4.496', 'groupId': 'BG005'}, {'value': '30.26', 'spread': '11.193', 'groupId': 'BG006'}, {'value': '25.37', 'spread': '4.913', 'groupId': 'BG007'}, {'value': '26.95', 'spread': '4.944', 'groupId': 'BG008'}, {'value': '27.47', 'spread': '4.559', 'groupId': 'BG009'}, {'value': '33.07', 'spread': '9.447', 'groupId': 'BG010'}, {'value': '22.14', 'groupId': 'BG011'}, {'value': '27.52', 'spread': '7.757', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-04', 'size': 1285678, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-14T13:43', 'hasProtocol': True}, {'date': '2020-03-24', 'size': 1322717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-14T13:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2015-02-26', 'resultsFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-12', 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)', 'description': 'A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes:\n\nA hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants):\n\n* Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection\n* CTCAE Grade 4 neutropenia lasting \\>7 days\n* CTCAE Grade 4 thrombocytopenia\n* CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion\n* CTCAE Grade 4 anemia\n\nA non-hematologic DLT is defined as:\n\n* CTCAE Grade 4 tumor lysis syndrome\n* CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia)\n* CTCAE Grade 3 or higher hypersensitivity reaction\n* CTCAE Grade 2 or higher skin ulceration\n* CTCAE Grade 2 or higher peripheral sensory or motor neuropathy'}, {'measure': 'Recommended Dose of Camidanlumab Tesirine for Part 2', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)', 'description': 'The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.'}, {'measure': 'Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.'}, {'measure': 'Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)', 'timeFrame': 'Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after treatment; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'ORR is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine.\n\nTumor response was assessed using the 2014 Lugano Classification.\n\nCR is defined as achieving each of the following:\n\n* Complete metabolic response.\n* Complete radiologic response (target node regress to \\<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).\n\nPR is defined as achieving each of the following:\n\n* Partial metabolic response (findings indicate residual disease).\n* Partial remission (\\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \\>50% in length and no new lesions).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'DoR is defined among responders (complete response \\[CR\\] and partial response \\[PR\\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification.\n\nDisease progression is defined as progressive metabolic disease and one of the follow:\n\n* Target node progression.\n* An individual extranodal lesion must be abnormal with length \\> 1.5cm and/or increase of length \\> 50%.\n* New or clear progression of nonmeasured lesions.\n* Regrowth of previously resolved lesions or new nodes \\>1.5 cm in length.\n* New or recurrent bone marrow involvement.\n\nDoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.\n\nDisease progression is defined as progressive metabolic disease and one of the following:\n\n* Target node progression.\n* An individual extranodal lesion must be abnormal with length \\> 1.5cm and/or increase of length \\> 50%.\n* New or clear progression of nonmeasured lesions.\n* Regrowth of previously resolved lesions or new nodes \\> 1.5 cm in length.\n* New or recurrent bone marrow involvement.\n\nPFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause.\n\nOS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)', 'description': 'AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)', 'description': 'AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.'}, {'measure': 'Accumulation Index (AI) for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.'}, {'measure': 'Volume of Distribution for Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Clearance of Camidanlumab Tesirine', 'timeFrame': 'Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)', 'description': 'Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).'}, {'measure': 'Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine', 'timeFrame': 'Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])', 'description': 'An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Camidanlumab tesirine'], 'conditions': ['Hodgkin Lymphoma', 'Non-Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '36333464', 'type': 'DERIVED', 'citation': 'Toukam M, Wuerthner J, Havenith K, Hamadani M, Caimi PF, Kopotsha T, Cruz HG, Boni JP. Population pharmacokinetics analysis of camidanlumab tesirine in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):13-24. doi: 10.1007/s00280-022-04486-4. Epub 2022 Nov 4.'}, {'pmid': '36333463', 'type': 'DERIVED', 'citation': 'Toukam M, Boni JP, Hamadani M, Caimi PF, Cruz HG, Wuerthner J. Exposure-response analysis of Camidanlumab tesirine in patients with relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):1-12. doi: 10.1007/s00280-022-04487-3. Epub 2022 Nov 4.'}, {'pmid': '34048682', 'type': 'DERIVED', 'citation': 'Hamadani M, Collins GP, Caimi PF, Samaniego F, Spira A, Davies A, Radford J, Menne T, Karnad A, Zain JM, Fields P, Havenith K, Cruz HG, He S, Boni J, Feingold J, Wuerthner J, Horwitz S. Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study. Lancet Haematol. 2021 Jun;8(6):e433-e445. doi: 10.1016/S2352-3026(21)00103-4.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.', 'detailedDescription': 'This is a Phase I, first in human clinical study with camidanlumab tesirine to evaluate the safety and tolerability and pharmacokinetics of camidanlumab tesirine in participants with relapsed/refractory lymphoma.\n\nCamidanlumab tesirine is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.\n\nThe study will be conducted in 2 parts: Part 1 (dose escalation) and Part 2 (expansion).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female age 18 years or older.\n2. Refractory or relapsed lymphoma (per World Health Organization (WHO) Classification system)\n3. Pathologically confirmed relapsed or refractory lymphoma\n4. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.\n5. Measurable disease, defined by the 2014 Lugano Classification Criteria and Global Response Score Grading Scales for cutaneous T-cell lymphoma (CTCL)\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n7. Absolute neutrophil count ≥1500/µL. Criterion not applicable to adult T cell leukemia/lymphoma (ATLL) patients.\n8. Platelet count of ≥75000/µL. Criterion not applicable to ATLL patients.\n9. Hemoglobin ≥9.0 g/dL without transfusion within the 2 weeks prior to Day 1.\n10. Serum/plasma creatinine ≤1.5 mg/dL, or if the participant has a creatinine \\> 1.5 mg/dL, a measured creatinine clearance must be \\> 80 mL/min as calculated by the Cockcroft and Gault equation\n11. Serum alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase ≤2 times the upper limit of normal (ULN); ≤ 5 times ULN if there is liver or bone involvement.\n12. Total serum/plasma bilirubin ≤1.5 times ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 times ULN)\n13. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.\n14. Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.\n\nExclusion Criteria:\n\n1. Participants who have an option for any treatment with proven clinical benefit for their lymphoid malignancy at current state of disease.\n2. Active graft-versus-host disease.\n3. Autologous or allogenic transplant within the 60 days prior to Cycle 1 Day 1 (C1D1)\n4. Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.\n5. Known history of positive serum human anti-drug antibody (ADA) or known allergy to any component of ADCT-301.\n6. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \\[e.g., Wegener's granulomatosis\\])\n7. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis); other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).\n8. History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens listed: herpes simplex virus Type 1 (HSV1), herpes simplex virus Type 2 (HSV2), varicella zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.\n9. Known seropositive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or antibody to hepatitis C virus (anti-HCV) with confirmatory testing and requiring anti-viral therapy. Note: testing is not mandatory to be eligible.\n\n If participant is at risk for having undiagnosed hepatitis C virus (HCV) (e.g., history of injection drug use), HCV testing should be considered.\n10. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n11. Pregnant or breastfeeding women.\n12. Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \\> 115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.\n13. Use of any other experimental medication(s) within 14 days or 5 half-lives, but in no case \\< 14 days prior to the start of study treatment on Cycle 1, Day 1, except if approved by the Sponsor.\n14. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy (including prednisone ≥ 40 mg/day or equivalent) within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by the Sponsor.\n15. Failure to recover (to Common Terminology Criteria for Adverse Events \\[CTCAE Version 4.0\\] Grade 0 or Grade 1) from acute non-hematologic toxicity (except all grades of alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.\n16. Congenital long QT syndrome or a corrected QT interval (QTc)≥ 450 ms at screening (unless secondary to pacemaker or bundle branch block).\n17. Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that Sponsor Medical Monitor and Investigator agree, and document should not be exclusionary.\n18. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk."}, 'identificationModule': {'nctId': 'NCT02432235', 'briefTitle': 'Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADC Therapeutics S.A.'}, 'officialTitle': 'A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'ADCT-301-001'}, 'secondaryIdInfos': [{'id': '2015-005272-25', 'type': 'EUDRACT_NUMBER'}, {'id': '199948', 'type': 'REGISTRY', 'domain': 'HRA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '5 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '8 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '13 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '20 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '30 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '45 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '60 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '80 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '100 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '150 μg/kg', 'description': 'Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.', 'interventionNames': ['Drug: Camidanlumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': '300 μg/kg', 'description': 'A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).', 'interventionNames': ['Drug: Camidanlumab tesirine']}], 'interventions': [{'name': 'Camidanlumab tesirine', 'type': 'DRUG', 'otherNames': ['ADCT-301', 'Cami'], 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['100 μg/kg', '13 μg/kg', '150 μg/kg', '20 μg/kg', '3 μg/kg', '30 μg/kg', '300 μg/kg', '45 μg/kg', '5 μg/kg', '60 μg/kg', '8 μg/kg', '80 μg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope (City of Hope National Medical Center, City of Hope Medical Center)', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'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': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas/MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital/Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas' Hospital NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Churchill Hospital, Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital, University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Jens Wuerthner, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADC Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADC Therapeutics S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}