Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT01741792
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen, Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.', 'description': 'Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014.\n\nOther Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Cohort 2: Blinatumomab 112 µg/d', 'description': 'Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Cohort 1+3: Blinatumomab 9/28/112µg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.', 'otherNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'seriousNumAffected': 21}, {'id': 'EG004', 'title': 'Blinatumomab Overall', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 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'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematoma', 'stats': 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'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bone marrow toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 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'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG003', 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Drug administration error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Objective Response Rate During Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '30.8', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first 8 weeks', 'description': 'Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).\n\nComplete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Best Overall Response of Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '45.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first 8 weeks', 'description': 'Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Best Overall Response of Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '45.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first 8 weeks', 'description': 'Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (\\<50% decrease in size of masses) of measureable disease and no new sites.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set with an overall objective response of CR or PR during the first treatment cycle'}, {'type': 'SECONDARY', 'title': 'Duration of Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set with a best overall response of CR during the first treatment cycle'}, {'type': 'SECONDARY', 'title': 'Duration of Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '5.8'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set with a best overall response of PR during the first treatment cycle'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '14.1'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.', 'description': 'The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.', 'description': 'The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG001', 'title': 'Cohort 2: Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'OG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 μg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'AE of Grade ≥ 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'AE of Grade ≥ 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse event (SAE)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Led to interruption of study drug', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Related adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Related AE Grade ≥ 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Related AE Grade ≥ 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serious related adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related AE led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related AE led to interruption of study drug', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.', 'description': 'Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.\n\nAn adverse event or suspected adverse drug reaction was considered "serious" if it resulted in one of the following outcomes:\n\n* Resulted in death;\n* Was life-threatening;\n* Required inpatient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;\n* Was a congenital anomaly or birth defect;\n* Was a medically important condition.\n\nThe Investigator used medical judgment to determine whether there was a causal relationship (ie, related \\[reasonably possible\\] or unrelated \\[not reasonably possible\\]) between an adverse event and blinatumomab.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Blinatumomab Steady State Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab 9 μg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.'}, {'id': 'OG001', 'title': 'Blinatumomab 28 μg/d', 'description': 'Participants received blinatumomab CIV 28 µg/day.'}, {'id': 'OG002', 'title': 'Blinatumomab 112 μg/d', 'description': 'Participants received blinatumomab administered CIV 112 µg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '277', 'spread': '210', 'groupId': 'OG000'}, {'value': '565', 'spread': '208', 'groupId': 'OG001'}, {'value': '2800', 'spread': '1150', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)', 'description': 'Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).'}, {'type': 'SECONDARY', 'title': 'Leukocyte Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '6.376', 'spread': '3.284', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '5.729', 'spread': '2.891', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '6.819', 'spread': '3.201', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '6.400', 'spread': '2.486', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '3.764', 'spread': '2.160', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '4.950', 'spread': '3.819', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '4.611', 'spread': '2.114', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '6.850', 'spread': '2.818', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '4.820', 'spread': '1.616', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '5.183', 'spread': '1.380', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '4.425', 'spread': '0.854', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '5.700', 'spread': '1.424', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '4.767', 'spread': '0.874', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '6.467', 'spread': '1.779', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '5.450', 'spread': '0.495', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '4.533', 'spread': '1.069', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'Lymphocyte Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.779', 'spread': '0.425', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.491', 'spread': '0.259', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.382', 'spread': '0.215', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.277', 'spread': '0.165', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.472', 'spread': '0.273', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.847', 'spread': '0.511', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.767', 'spread': '0.505', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '1.060', 'spread': '0.489', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '1.053', 'spread': '0.421', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '1.120', 'spread': '0.621', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '1.048', 'spread': '0.381', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '1.120', 'spread': '0.449', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.998', 'spread': '0.527', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.565', 'spread': '0.180', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '1.205', 'spread': '0.839', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.737', 'spread': '0.478', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Lymphocyte counts were analyzed by differential blood count analysis.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'Monocyte Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.638', 'spread': '0.415', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.300', 'spread': '0.565', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.202', 'spread': '0.386', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.188', 'spread': '0.317', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.318', 'spread': '0.185', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.646', 'spread': '0.375', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.473', 'spread': '0.241', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.711', 'spread': '0.569', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.585', 'spread': '0.280', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.487', 'spread': '0.239', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.452', 'spread': '0.112', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.469', 'spread': '0.061', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.511', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.290', 'spread': '0.123', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.516', 'spread': '0.008', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.234', 'spread': '0.176', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'Granulocyte Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '4.968', 'spread': '3.187', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '4.910', 'spread': '2.425', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '6.235', 'spread': '2.881', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '5.935', 'spread': '2.387', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '2.974', 'spread': '2.019', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '3.457', 'spread': '3.395', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '3.353', 'spread': '2.134', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '5.080', 'spread': '3.012', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '3.182', 'spread': '1.117', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '3.594', 'spread': '0.950', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '2.925', 'spread': '0.675', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '4.111', 'spread': '1.382', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '3.258', 'spread': '0.745', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '5.612', 'spread': '1.713', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '3.729', 'spread': '0.352', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '3.563', 'spread': '0.711', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD19+ B-Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.072', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.085', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.002', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.001', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.001', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.001', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.002', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.026', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.043', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.066', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.082', 'spread': '0.113', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.094', 'spread': '0.118', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.071', 'spread': '0.075', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.131', 'spread': '0.170', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.108', 'spread': '0.120', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD19+ B-Cells as a Percentage of All Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '2', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '4', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '2', 'spread': '2', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '2', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '5', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '7', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '7', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '11', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '8', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '12', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD3+ T-Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.578', 'spread': '0.355', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.349', 'spread': '0.233', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.282', 'spread': '0.194', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.199', 'spread': '0.159', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.348', 'spread': '0.231', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.613', 'spread': '0.426', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.543', 'spread': '0.421', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.825', 'spread': '0.431', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.773', 'spread': '0.443', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.782', 'spread': '0.345', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.671', 'spread': '0.184', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.703', 'spread': '0.203', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.594', 'spread': '0.227', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.298', 'spread': '0.049', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.623', 'spread': '0.266', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.456', 'spread': '0.257', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD3+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD3+ T-Cells as a Percentage of All Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '72', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '68', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '70', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '67', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '73', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '71', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '66', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '76', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '73', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '66', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '66', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '65', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '61', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '57', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '58', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '63', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD3+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. 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All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ T-Cells as a Percentage of All Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '33', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '28', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '32', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '29', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '34', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '30', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '28', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '32', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '33', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '30', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '31', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '35', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '31', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '32', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '29', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '34', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ T-Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.298', 'spread': '0.256', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.136', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.134', 'spread': '0.099', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.102', 'spread': '0.095', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.140', 'spread': '0.076', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.299', 'spread': '0.237', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.284', 'spread': '0.195', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.438', 'spread': '0.284', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.381', 'spread': '0.254', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.403', 'spread': '0.304', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.225', 'spread': '0.039', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.310', 'spread': '0.200', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.214', 'spread': '0.023', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.105', 'spread': '0.057', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.185', 'spread': '0.026', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.187', 'spread': '0.068', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ T-Cells as a Percentage of All Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '37', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '37', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '35', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '35', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '33', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '37', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '36', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '43', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '36', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '34', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '25', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '28', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '24', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '21', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '20', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '27', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD19+ B-Cell to CD3+ T-Cell Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ T-Cell to CD8+ T-Cell Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '2.23', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '1.85', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ Naive T Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.056', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.022', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.033', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.024', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.071', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.060', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.088', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.083', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.019', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.044', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.090', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.084', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.044', 'spread': '0.059', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.035', 'spread': '0.041', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.098', 'spread': '0.103', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.013', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '8', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '7', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '7', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '10', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '9', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '10', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '8', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '9', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '4', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '4', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '11', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '12', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '10', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '19', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '23', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '8', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD4+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ Central Memory T-Cell (TCM) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.034', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.042', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.025', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.065', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.035', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.103', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.062', 'spread': '0.075', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.020', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.043', 'spread': '0.056', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.073', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.020', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.031', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.056', 'spread': '0.054', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.010', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ TCM Cells as a Percentage of All CD4+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '18', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '20', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '19', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '14', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '13', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '13', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '15', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '14', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '6', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '9', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '11', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '18', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '13', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '18', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '14', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '12', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD4+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ Effector Memory T-Cell (TEM) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.161', 'spread': '0.089', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.099', 'spread': '0.096', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.083', 'spread': '0.076', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.044', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.097', 'spread': '0.059', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.169', 'spread': '0.117', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.140', 'spread': '0.091', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.220', 'spread': '0.142', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.279', 'spread': '0.153', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.267', 'spread': '0.158', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.191', 'spread': '0.037', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.226', 'spread': '0.100', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.199', 'spread': '0.087', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.106', 'spread': '0.066', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.181', 'spread': '0.107', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.175', 'spread': '0.133', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD4+ TEM Cells as a Percentage of All CD4+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '41', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '39', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '36', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '46', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '34', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '39', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '41', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '41', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '46', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '41', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '42', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '40', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '46', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '43', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '45', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '51', 'spread': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD4+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ Naive T-Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.043', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.050', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.012', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.005', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.014', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.036', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.015', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.018', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.007', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.022', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.012', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.011', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.008', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.006', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.009', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '10', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '12', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '9', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '8', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '8', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '6', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '3', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '6', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '4', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '5', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '6', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '6', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '6', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '10', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '8', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '10', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD8+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ TCM Cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.027', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.021', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.013', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.005', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.007', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.015', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.023', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.003', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.014', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.004', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.010', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.002', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.001', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.001', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.004', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '100 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ TCM Cells as a Percentage of All CD8+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '7', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '8', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '10', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '4', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '7', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '9', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '5', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '5', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '4', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '3', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '6', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD8+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ Effector Memory T-Cell (TEM) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.127', 'spread': '0.162', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.075', 'spread': '0.066', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.058', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.067', 'spread': '0.039', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.135', 'spread': '0.108', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.128', 'spread': '0.077', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.180', 'spread': '0.089', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.146', 'spread': '0.071', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.179', 'spread': '0.158', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.116', 'spread': '0.061', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.174', 'spread': '0.162', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.095', 'spread': '0.025', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.027', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.085', 'spread': '0.013', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.027', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ TEM Cells as a Percentage of All CD8+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '42', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '42', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '46', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '43', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '51', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '46', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '51', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '49', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '47', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '50', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '50', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '51', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '46', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '46', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '46', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '33', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD8+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '0.123', 'spread': '0.099', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.069', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.042', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.048', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.050', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '0.132', 'spread': '0.126', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '0.135', 'spread': '0.131', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '0.226', 'spread': '0.249', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '0.214', 'spread': '0.220', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '0.187', 'spread': '0.182', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.094', 'spread': '0.046', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '0.117', 'spread': '0.065', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.099', 'spread': '0.041', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.035', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '0.086', 'spread': '0.016', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '0.100', 'spread': '0.084', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.', 'unitOfMeasure': '1000 cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}, {'type': 'SECONDARY', 'title': 'CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinatumomab', 'description': 'All participants who received blinatumomab by continuous intravenous infusion during the core study.'}], 'classes': [{'title': 'Screening (N = 25)', 'categories': [{'measurements': [{'value': '41', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 Prior (N = 24)', 'categories': [{'measurements': [{'value': '39', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 21)', 'categories': [{'measurements': [{'value': '36', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 16)', 'categories': [{'measurements': [{'value': '46', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N = 11)', 'categories': [{'measurements': [{'value': '34', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 (N = 8)', 'categories': [{'measurements': [{'value': '39', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'End of Infusion (N = 9)', 'categories': [{'measurements': [{'value': '41', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'End of Core Study (N = 6)', 'categories': [{'measurements': [{'value': '41', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': '3-Month Follow-up (N = 5)', 'categories': [{'measurements': [{'value': '46', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': '6-Month Follow-up (N = 6)', 'categories': [{'measurements': [{'value': '41', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '9-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '42', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': '12-Month Follow-up (N = 4)', 'categories': [{'measurements': [{'value': '40', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '15-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '46', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': '18-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '43', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': '21-Month Follow-up (N = 21)', 'categories': [{'measurements': [{'value': '45', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': '24-Month Follow-up (N = 3)', 'categories': [{'measurements': [{'value': '51', 'spread': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.', 'unitOfMeasure': 'percentage of CD8+ T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'FG001', 'title': 'Cohort 2: Blinatumomab 112 µg/d', 'description': 'Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'FG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3 participants were not considered evaluable and were replaced as specified in the protocol.', 'groupId': 'FG000', 'numSubjects': '9'}, {'comment': 'Cohort 2 was closed to enrollment on recommendation of the data monitoring committee', 'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Efficacy Set', 'achievements': [{'comment': 'Completed \\> 7 days of infusion on the highest intended dose level or discontinued due to progression', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Completed \\> 7 days of infusion on the highest intended dose level or discontinued due to progression', 'groupId': 'FG001', 'numSubjects': '1'}, {'comment': 'Completed \\> 7 days of infusion on the highest intended dose level or discontinued due to progression', 'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Adults with a diagnosis of diffuse large B-cell lymphoma (DLBCL) which was refractory to first or subsequent treatment or who had a first or later relapse and were not eligible for autologous hematopoietic stem cell transplant (HSCT), or relapsed after autologous HSCT were eligible to enrol.\n\nThe primary analysis cut-off date was 10 July 2014.', 'preAssignmentDetails': 'The study was conducted sequentially in 2 stages and 3 cohorts: In Stage 1, Cohort 1 received an escalating dose of 9/28/112 µg/day blinatumomab and Cohort 2 received a constant dose of 112 µg/day for 8 weeks. In Stage 2, the Cohort 3 dose regimen was determined from the outcome of Cohorts 1 and 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'BG001', 'title': 'Cohort 2: Blinatumomab 112 µg/d', 'description': 'Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'BG002', 'title': 'Cohort 3: Blinatumomab 9/28/112 µg/d', 'description': 'Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '13.6', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Relapsed/refractory Status to Last Prior Treatment', 'classes': [{'title': 'Relapsed', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Refractory', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Previous Autologous Hematopoietic Stem Cell Transplants (HSCT)', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': '≥ 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2012-11-28', 'resultsFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-26', 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Objective Response Rate During Treatment Cycle 1', 'timeFrame': 'During the first 8 weeks', 'description': 'Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).\n\nComplete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Best Overall Response of Complete Response', 'timeFrame': 'During the first 8 weeks', 'description': 'Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.'}, {'measure': 'Percentage of Participants With a Best Overall Response of Partial Response', 'timeFrame': 'During the first 8 weeks', 'description': 'Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (\\<50% decrease in size of masses) of measureable disease and no new sites.'}, {'measure': 'Duration of Objective Response', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.'}, {'measure': 'Duration of Complete Response', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.'}, {'measure': 'Duration of Partial Response', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.', 'description': 'The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.', 'description': 'The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.', 'description': 'The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.', 'description': 'Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.\n\nAn adverse event or suspected adverse drug reaction was considered "serious" if it resulted in one of the following outcomes:\n\n* Resulted in death;\n* Was life-threatening;\n* Required inpatient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;\n* Was a congenital anomaly or birth defect;\n* Was a medically important condition.\n\nThe Investigator used medical judgment to determine whether there was a causal relationship (ie, related \\[reasonably possible\\] or unrelated \\[not reasonably possible\\]) between an adverse event and blinatumomab.'}, {'measure': 'Blinatumomab Steady State Serum Concentration', 'timeFrame': 'Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)', 'description': 'Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.'}, {'measure': 'Leukocyte Counts', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.'}, {'measure': 'Lymphocyte Counts', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Lymphocyte counts were analyzed by differential blood count analysis.'}, {'measure': 'Monocyte Counts', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment'}, {'measure': 'Granulocyte Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment'}, {'measure': 'CD19+ B-Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD19+ B-Cells as a Percentage of All Lymphocytes', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD3+ T-Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD3+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD3+ T-Cells as a Percentage of All Lymphocytes', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD3+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD4+ T-Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD4+ T-Cells as a Percentage of All Lymphocytes', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD8+ T-Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD8+ T-Cells as a Percentage of All Lymphocytes', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD19+ B-Cell to CD3+ T-Cell Ratio', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD4+ T-Cell to CD8+ T-Cell Ratio', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.'}, {'measure': 'CD4+ Naive T Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD4+ Central Memory T-Cell (TCM) Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD4+ TCM Cells as a Percentage of All CD4+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD4+ Effector Memory T-Cell (TEM) Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD4+ TEM Cells as a Percentage of All CD4+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ Naive T-Cell Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ TCM Cell Counts', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ TCM Cells as a Percentage of All CD8+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ Effector Memory T-Cell (TEM) Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ TEM Cells as a Percentage of All CD8+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.'}, {'measure': 'CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.'}, {'measure': 'CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells', 'timeFrame': 'Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment', 'description': 'Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Relapsed DLBCL', 'Refractory DLBCL', 'adult DLBCL', 'Lymphoma', 'Non-Hodgkin Lymphoma', 'Lymphatic diseases', 'Lymphoproliferative disorders', 'bispecific antibody', 'anti-CD19', 'Immunotherapeutic treatment', 'Immunoproliferative disorders'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '27209293', 'type': 'DERIVED', 'citation': 'Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.'}, {'pmid': '26755709', 'type': 'DERIVED', 'citation': 'Viardot A, Goebeler ME, Hess G, Neumann S, Pfreundschuh M, Adrian N, Zettl F, Libicher M, Sayehli C, Stieglmaier J, Zhang A, Nagorsen D, Bargou RC. Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6. doi: 10.1182/blood-2015-06-651380. Epub 2016 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'detailedDescription': 'DLBCL is an aggressive malignant disease which evolves from B-cells and affects mainly the lymphatic tissue. Due to its aggressive nature the disease is characterized by a fast course which is lethal without therapy. Potentially curative therapy options are available even at advanced stages. Standard-first line leads to a high initial response rate (85-90%) and an approximate cure rate of 50% of patients. Patients refractory to or with early relapse after this treatment (10-15%) have a very poor prognosis.\n\nBlinatumomab is a bispecific single-chain antibody derivative against CD19 and CD3, designed to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against CD19 expressing cells.\n\nThis study consisted of a screening period, treatment period, and a follow-up efficacy and survival period. The core study comprises the treatment period to the 30 days after the last infusion. The first cycle consisted of a continuous intravenous (CIV) infusion over 8 weeks. Participants who achieved a Complete Response (CR) or Partial Response (PR) or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. After the last treatment cycle, efficacy and survival follow-up visits occurred for up to 24 months from treatment start. Participants who relapsed during the follow-up period may have received an additional 8 weeks of treatment.\n\nTwo dose regimens were assessed in this study. Stage 1 comprised 2 dose cohorts. In Cohort 1, the first 6 participants were to receive blinatumomab in a dose-escalating manner: 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. In Cohort 2, the next 6 participants enrolled were to receive a constant dose of 112 µg/day blinatumomab. Before the initiation of stage 2, a pre-planned data monitoring committee (DMC) meeting was held to assess the safety profile of Cohort 1 and Cohort 2. The dosing regimen with the more favorable benefit-risk profile was to be selected for Cohort 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Diffuse Large B-Cell Lymphoma (DLBCL) who are refractory to first or later treatment or have a first relapse or later relapse not eligible for autologous hematopoietic stem cell transplant (HSCT) or relapsed post- autologous-HSCT\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Age ≥ 18 years\n* Life expectancy of ≥ 12 weeks\n* Cerebrospinal fluid (CSF) free of infiltration by DLBCL\n\nExclusion Criteria:\n\n* History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson\'s disease, cerebellar disease, organic brain syndrome, psychosis\n* Current infiltration of CSF by DLBCL\n* History of autoimmune disease with potential CNS involvement or current autoimmune disease\n* Autologous HSCT within six weeks prior to start of blinatumomab treatment\n* Prior allogeneic HSCT\n* Cancer chemotherapy within two weeks prior to start of blinatumomab treatment\n* Radiotherapy within four weeks prior to start of blinatumomab treatment\n* Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment\n* Any investigational anti-lymphoma product within four weeks prior to start of blinatumomab treatment\n* Treatment with any other investigational product after signature of informed consent\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation\n* Abnormal laboratory values indicative of inadequate renal or liver function\n* History of malignancy other than non-Hodgkin\'s lymphoma (NHL) within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix\n* Active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator\n* Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus\n* Pregnant or nursing women\n* Previous treatment with blinatumomab\n* Presence of human anti-murine antibodies (HAMA) at screening'}, 'identificationModule': {'nctId': 'NCT01741792', 'briefTitle': 'Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen Research (Munich) GmbH'}, 'officialTitle': 'An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE®) Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'orgStudyIdInfo': {'id': 'MT103-208'}, 'secondaryIdInfos': [{'id': '2011-005781-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blinatumomab', 'description': 'By study design, two dose regimens were assessed in this study. In Stage 1, Cohort 1, participants received blinatumomab in a dose-escalating manner: 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during cycle 1. In Cohort 2, the next participants enrolled and received a constant dose of 112 µg/day blinatumomab. The dosing regimen with the more favorable benefit-risk profile was then selected for Stage 2, Cohort 3.', 'interventionNames': ['Drug: Blinatumomab']}], 'interventions': [{'name': 'Blinatumomab', 'type': 'DRUG', 'otherNames': ['AMG103', 'MT103', 'BLINCYTO®'], 'description': 'Administered by continuous intravenous infusion over 8 weeks in the first cycle and 4 weeks in the second cycle.', 'armGroupLabels': ['Blinatumomab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes-Gutenberg Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universititätsklinikum', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': '- MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen Research (Munich) GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}