Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01453205
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2011-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609745', 'term': 'inebilizumab'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D007053', 'term': 'Ice'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '301-398-4095', 'title': 'Mohammed Dar', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'AE were reported for safety population, which included all participants who received any study treatment..', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'otherNumAtRisk': 79, 'otherNumAffected': 78, 'seriousNumAtRisk': 79, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'otherNumAtRisk': 52, 'otherNumAffected': 49, 'seriousNumAtRisk': 52, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'otherNumAtRisk': 54, 'otherNumAffected': 52, 'seriousNumAtRisk': 54, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 113, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 87, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 111, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 31, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 50, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 30, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 45, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 172, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 71, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 114, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 38, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 75, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 45, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 42, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 33, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 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'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '36.2', 'upperLimit': '59.0'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '32.2', 'upperLimit': '60.5'}, {'value': '43.6', 'groupId': 'OG002', 'lowerLimit': '30.3', 'upperLimit': '57.7'}]}]}], 'analyses': [{'pValue': '0.5543', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (\\>=) 50% decrease in SPD of spleen/liver nodules.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '39.2'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '31.3'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '14.8'}]}]}], 'analyses': [{'pValue': '0.8567', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. PFS (months) = (Date of PD/death or censoring - Date of randomization + 1) / (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '39.2'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '31.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '14.8'}]}]}], 'analyses': [{'pValue': '0.7412', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Event-Free Survival (EFS) is defined as the time from randomization until the first documentation of EFS events which include PD, initiation of alternative antitumor treatment or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. EFS (months) = (Date of EFS or censoring - Date of randomization + 1) / (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates data not estimable.', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates data not estimable.', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': 'NA'}, {'value': '23.0', 'comment': 'NA indicates data not estimable.', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9996', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Overall survival is defined as the time from randomization until death due to any cause according to the International Working Group criteria. OS (months) = (Date of death or censoring - Date of randomization + 1) / (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.1'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '31.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '14.0'}]}]}], 'analyses': [{'pValue': '0.1686', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Time to Progression (TTP) is defined as the time from randomization until the first documentation of PD according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. TTP (months) = (Date of PD or censoring - Date of randomization + 1) / (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.8'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Time to response (TTR) is defined as the time from randomization until the first documentation of disease response according to the International Working Group criteria. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules. TTR (months) = (Date of first disease response - Date of randomization + 1) / (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized into the study. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates data not estimable.', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': 'NA'}, {'value': '7.1', 'comment': 'NA indicates data not estimable.', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': 'NA'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '12.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Duration of Response (DR) is defined as time from start of first documented objective response (confirmed CR or confirmed PR) to first documented PD according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules. PD: appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\> 50% increase from nadir in the SPD of any previous lesions. Only participants who have achieved objective response assessed by investigator were evaluated. DR calculated as (months) = (Date of PD or censoring - Date of first disease response + 1)/ (365.25/12).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'COMPLETE RESPONSE (CR)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '35.9'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '23.4'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '35.0'}]}]}, {'title': 'PARTIAL RESPONSE (PR)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'STABLE DISEASE (SD)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'PROGRESSIVE DISEASE (PD)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'UNKNOWN', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: CR, PR, stable disease (SD), PD, and unknown. Responses were assessed according to the International Working Group criteria. CR: disappearance of all evidence of disease; PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Acceptable Dose of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551', 'description': 'Participants were received MEDI-551 2 mg/kg or 4 mg/kg by IV infusion. Recommended MEDI-551 dose was selected based on the DMC reviews.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days)', 'description': 'Acceptable dose for MEDI-551 was evaluated based on the benefit-risk analysis.', 'unitOfMeasure': 'milligram per kilogram (mg/kg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized into the study and received MEDI-551.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Hematology/Coagulation Laboratory Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Granulocytopenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Pancytopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Thromobocytopenia', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Activated partial thromboplastin time prolonged', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood immunoglobulin g decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood immunoglobulin m decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Haemoglobin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Immunoglobulins decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An abnormal laboratory finding that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment (EOT).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Chemistry Laboratory Results (Include Urinalysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'Hyperbilirubinaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatraemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperphosphataemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypertriglyerideaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricaemia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcaemia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hypoglycaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalaemia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesaemia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatraemia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypophosphataemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypoproteinaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood bicarbonate decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood chloride increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Blood lactate dehydrogenase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood magnesium decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood potassium decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood uric acid decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood uric acid increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic enzyme increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Protein total decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Transaminases increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dysuria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hematuria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Glucose urine present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Urine sodium increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Calcium deficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Electrolyte imbalance', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An abnormal laboratory findings that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and ECG Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Extrasystoles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sinus arrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sinus bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Systolic dysfunction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Carbon dioxide decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Electrocardiogram abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Electrocardiogram QT prolonged', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate irregular', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Weight increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnoea exertional', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Vital signs included parameters such as heart rate, blood pressure, temperature, and respiratory rate. An abnormal vital signs and ECG findings that was judged by the investigator to be clinically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days before the start of Cycle 1, Day 1 of each subsequent Cycle, EOT, and post EOT on Days 30, 60, 90 and 270 (up to 36 months from the randomization of last participant)', 'description': 'A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study treatment.'}, {'type': 'SECONDARY', 'title': 'Mean Serum Concentration of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'Cycle 1 Day-7 Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.0', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '21.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1 Pre Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1 Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.8', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '116', 'spread': '41.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '25.1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 Pre Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.3', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '112', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 Pre Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.4', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '116', 'spread': '30.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day -7 Post dose, pre-dose and postdose on Day 1, post-dose on Days 4, 8, 15 of Cycle 1, pre-dose and postdose on Day 1 of Cycle 2 and Cycle 3', 'description': 'The mean serum concentration of MEDI-551 were observed.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received MEDI-551 were analyzed for this end point.'}, {'type': 'SECONDARY', 'title': 'Half-life (T1/2) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'OG001', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '5.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and EOT (Day 21 of Cycle 3 [each cycle of 21 days] or earlier cycles if treatment stopped before Cycle 3)', 'description': 'Terminal elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received MEDI-551 were analyzed for this end point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'FG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'FG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '35'}]}]}], 'recruitmentDetails': 'The study was conducted from 27Feb2012 to 17Jun2016.', 'preAssignmentDetails': 'A total of 256 participants were screened, of which 187 participants were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab+ ICE/DHAP', 'description': 'Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'BG001', 'title': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'BG002', 'title': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.'}, {'id': 'BG003', 'title': 'TOTAL', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 YEARS', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}, {'title': '>= 65 YEARS', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-To-Treat population included all participants who were randomized into the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'dispFirstSubmitDate': '2017-06-29', 'completionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2011-10-03', 'dispFirstSubmitQcDate': '2017-06-29', 'resultsFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2011-10-14', 'dispFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-08', 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (\\>=) 50% decrease in SPD of spleen/liver nodules.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. PFS (months) = (Date of PD/death or censoring - Date of randomization + 1) / (365.25/12).'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Event-Free Survival (EFS) is defined as the time from randomization until the first documentation of EFS events which include PD, initiation of alternative antitumor treatment or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. EFS (months) = (Date of EFS or censoring - Date of randomization + 1) / (365.25/12).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Overall survival is defined as the time from randomization until death due to any cause according to the International Working Group criteria. OS (months) = (Date of death or censoring - Date of randomization + 1) / (365.25/12).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Time to Progression (TTP) is defined as the time from randomization until the first documentation of PD according to the International Working Group criteria. PD is defined as appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions. TTP (months) = (Date of PD or censoring - Date of randomization + 1) / (365.25/12).'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Time to response (TTR) is defined as the time from randomization until the first documentation of disease response according to the International Working Group criteria. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules. TTR (months) = (Date of first disease response - Date of randomization + 1) / (365.25/12).'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Duration of Response (DR) is defined as time from start of first documented objective response (confirmed CR or confirmed PR) to first documented PD according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules. PD: appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\> 50% increase from nadir in the SPD of any previous lesions. Only participants who have achieved objective response assessed by investigator were evaluated. DR calculated as (months) = (Date of PD or censoring - Date of first disease response + 1)/ (365.25/12).'}, {'measure': 'Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: CR, PR, stable disease (SD), PD, and unknown. Responses were assessed according to the International Working Group criteria. CR: disappearance of all evidence of disease; PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and \\>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \\>= 50% increase in SPD of more than one node or \\>= 50% increase in longest diameter of a previously identified node or \\>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD.'}, {'measure': 'Acceptable Dose of MEDI-551', 'timeFrame': 'After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days)', 'description': 'Acceptable dose for MEDI-551 was evaluated based on the benefit-risk analysis.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Hematology/Coagulation Laboratory Results', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An abnormal laboratory finding that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment (EOT).'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Chemistry Laboratory Results (Include Urinalysis)', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'An abnormal laboratory findings that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and ECG Abnormalities', 'timeFrame': 'From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)', 'description': 'Vital signs included parameters such as heart rate, blood pressure, temperature, and respiratory rate. An abnormal vital signs and ECG findings that was judged by the investigator to be clinically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.'}, {'measure': 'Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA)', 'timeFrame': '7 days before the start of Cycle 1, Day 1 of each subsequent Cycle, EOT, and post EOT on Days 30, 60, 90 and 270 (up to 36 months from the randomization of last participant)', 'description': 'A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.'}, {'measure': 'Mean Serum Concentration of MEDI-551', 'timeFrame': 'Cycle 1 Day -7 Post dose, pre-dose and postdose on Day 1, post-dose on Days 4, 8, 15 of Cycle 1, pre-dose and postdose on Day 1 of Cycle 2 and Cycle 3', 'description': 'The mean serum concentration of MEDI-551 were observed.'}, {'measure': 'Half-life (T1/2) of MEDI-551', 'timeFrame': 'Cycle 1 and EOT (Day 21 of Cycle 3 [each cycle of 21 days] or earlier cycles if treatment stopped before Cycle 3)', 'description': 'Terminal elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, B-Cell Malignancy, anti-CD19, monoclonal antibody, second line, ASCT, Refractory"], 'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL \\& Grade III FL\n* Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy\n* Eligible for ASCT\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Life expectancy of ≥ 12 weeks\n* Adequate hematological function\n\nExclusion Criteria:\n\n* Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment\n* Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy\n* Prior autologous or allogeneic SCT\n* New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG\n* History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.\n* Evidence of active infection\n* Documented current central nervous system involvement by leukemia or lymphoma'}, 'identificationModule': {'nctId': 'NCT01453205', 'briefTitle': 'A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL', 'orgStudyIdInfo': {'id': 'CD-ON-MEDI-551-1088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab+ ICE/DHAP', 'description': 'Participants will receive Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and will followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m\\^2) will be administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'interventionNames': ['Drug: Rituximab', 'Drug: ICE', 'Drug: DHAP', 'Procedure: Autologous Stem Cell Transplant (ASCT)']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 2 mg/kg + ICE/DHAP', 'description': 'Participants will receive MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and will be followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) will be administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'interventionNames': ['Drug: MEDI-551 2 mg/kg', 'Drug: ICE', 'Drug: DHAP', 'Procedure: Autologous Stem Cell Transplant (ASCT)']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 4 mg/kg + ICE/DHAP', 'description': 'Participants will receive MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and will be followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) will be administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m\\^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m\\^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m\\^2 continuously for 24 hours on Day 1; cytarabine 2 g/m\\^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'interventionNames': ['Drug: ICE', 'Drug: DHAP', 'Procedure: Autologous Stem Cell Transplant (ASCT)', 'Drug: MEDI-551 4 mg/kg']}], 'interventions': [{'name': 'MEDI-551 2 mg/kg', 'type': 'DRUG', 'otherNames': ['Inebilizumab'], 'description': 'MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).', 'armGroupLabels': ['MEDI-551 2 mg/kg + ICE/DHAP']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan; MabThera'], 'description': "Rituximab at 375 mg/m2 will be administered via IV infusion 2 days before the start of Cycle 1 and on Day 1 of each cycle. The infusion time for rituximab will be 50 400 mg/hr, depending on subject's tolerance. Subjects will receive 3 cycles of Rituximab with Ice (R ICE) or Rituximab with DHAP (R-DHAP) unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).", 'armGroupLabels': ['Rituximab+ ICE/DHAP']}, {'name': 'ICE', 'type': 'DRUG', 'description': 'ICE will be administered via IV infusion as follows: ifosfamide 5 g/m2 continuously for 24 hours with mesna on Days 2 and 3; carboplatin AUC=5 mg/mL x min \\[800 mg maximum) on Day 2; etoposide 100 mg/m2 on Days 1, 2, and 3) in 21-day cycles.', 'armGroupLabels': ['MEDI-551 2 mg/kg + ICE/DHAP', 'MEDI-551 4 mg/kg + ICE/DHAP', 'Rituximab+ ICE/DHAP']}, {'name': 'DHAP', 'type': 'DRUG', 'description': 'DHAP will be administered via IV infusion as follows: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m2 continuously for 24 hours on Day 1 of dosing cycle; cytarabine 2 g/m2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.', 'armGroupLabels': ['MEDI-551 2 mg/kg + ICE/DHAP', 'MEDI-551 4 mg/kg + ICE/DHAP', 'Rituximab+ ICE/DHAP']}, {'name': 'Autologous Stem Cell Transplant (ASCT)', 'type': 'PROCEDURE', 'description': 'Subjects who achieve CR or PR will undergo stem cell harvest and autologous stem cell transplantation (ASCT) following standard institutional protocols.', 'armGroupLabels': ['MEDI-551 2 mg/kg + ICE/DHAP', 'MEDI-551 4 mg/kg + ICE/DHAP', 'Rituximab+ ICE/DHAP']}, {'name': 'MEDI-551 4 mg/kg', 'type': 'DRUG', 'otherNames': ['Inebilizumab'], 'description': 'MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).', 'armGroupLabels': ['MEDI-551 4 mg/kg + ICE/DHAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35061', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91501', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.30778, 'lon': 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