Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT00299494
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2006-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'D000080045', 'term': 'Inotuzumab Ozogamicin'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded and reported from the time a participant signed the Informed Consent Form (ICF) until at least 28 days after last dose of study treatment. Summarized data reflects incidents from 1st dose to up to 56 days post last dose.', 'description': 'The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Inotuzumab Ozogamicin 0.8 mg/m^2+ Rituximab 375 mg/m^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Inotuzumab Ozogamicin 1.3 mg/m^2+ Rituximab 375 mg/m^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Inotuzumab Ozogamicin 1.8 mg/m^2+ Rituximab 375 mg/m^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Follicular', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 DLBCL', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 40, 'otherNumAffected': 39, 'seriousNumAtRisk': 40, 'seriousNumAffected': 12}, {'id': 'EG005', 'title': 'Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Refractory', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperfibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Catheter site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Crepitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oropharyngitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood bilirubin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood fibrinogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Monocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Urine protein/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Urine odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nipple pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Painful respiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': "Barrett's oesophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Visceroptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Candida pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pneumonia klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hepatocellular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Spider naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin (0.8 mg/m\\^2, 1.3 mg/m\\^2, or 1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28-day cycle', 'description': 'Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered MTD. The worldwide medical monitor and investigators reviewed all significant study drug-related toxicities to determine if the dose escalation rules were satisfied and whether the dose escalation schedule required modification.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat (ITT) Population: All participants included in the intended dose scheme. One additional participant was enrolled over the 6 planned participants in 1.8 mg/m\\^2 dose cohort because 1 participant was unevaluable for MTD evaluations.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': '% participants with a TEAE', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}, {'title': '% participants with serious TEAE', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '26.5', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}]}]}, {'title': '% participants with Grade 3 or 4 TEAE', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}, {'value': '67.6', 'groupId': 'OG003'}, {'value': '75.0', 'groupId': 'OG004'}, {'value': '63.3', 'groupId': 'OG005'}]}]}, {'title': '% participants with Grade 5 TEAE', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2.5', 'groupId': 'OG004'}, {'value': '6.7', 'groupId': 'OG005'}]}]}, {'title': '% participants for study drug discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '61.8', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}]}]}, {'title': '% participants with dose reduction due to TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '14.7', 'groupId': 'OG003'}, {'value': '10.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '% participants for study drug stopped temporarily', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '44.1', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '10.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.', 'description': 'A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All participants receiving at least 1 dose of inotuzumab ozogamicin or rituximab.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '29.2', 'upperLimit': '100'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '94.1', 'groupId': 'OG003', 'lowerLimit': '80.3', 'upperLimit': '99.3'}, {'value': '72.5', 'groupId': 'OG004', 'lowerLimit': '56.1', 'upperLimit': '85.4'}, {'value': '20', 'groupId': 'OG005', 'lowerLimit': '7.7', 'upperLimit': '38.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose', 'description': 'CR: a. Complete disappearance of all detectable clinical and radiographic evidence of disease, disease-related symptoms, and normalization of NHL assignable biochemical abnormalities ; b. lymph nodes and nodal masses must have regressed to normal size; c. Spleen regressed in size and not palpable on physical exam, size of other organs enlarged due to disease decreased in size; d. Repeat bone marrow infiltrate clear. CRu: CR but allows for a. Residual lymph node mass \\>1.5 cm in greatest transverse diameter has regressed by more than 75% in diameter. Individual nodes that were previously confluent regressed more than 75 % in their product diameters; b. Indeterminate bone marrow. PR: a. ≥50 % decrease in product of the diameters (SPD) of the 6 largest dominant nodes or nodal masses; b. No increase in size of other nodes, liver, or spleen, c. Liver or spleen nodules regressed ≥50% in the SPD; d. Other organs usually assessable, no measurable disease present.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all participants enrolled into the intended dose scheme. Using exact method based on binomial distribution.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'comment': 'insufficient data to calculate', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17.1', 'groupId': 'OG004', 'lowerLimit': '6.8', 'upperLimit': '56.6'}, {'value': '1.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose', 'description': 'The Kaplan-Meier method was used to determine PFS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>= 50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.8'}, {'value': '1.0', 'comment': 'Insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '0.8'}, {'value': '1.0', 'comment': 'Insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '0.8'}, {'value': '0.2', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose to 6 months after first dose', 'description': 'Progression Free Survival is defined as the time interval from the first dose of test article until the first date on which relapsed disease, progression, initiation of new anti-cancer treatment due to persistent/refractory disease, or death was documented, censored at the last tumor evaluation.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'comment': 'insufficient data to calculate', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': 'NA'}, {'value': '16.9', 'comment': 'insufficient data to calculate', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '58.3', 'comment': 'insufficient data to calculate', 'groupId': 'OG004', 'lowerLimit': '34.8', 'upperLimit': 'NA'}, {'value': '8.4', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '40.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose up to 5 years post last dose', 'description': 'OS was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of the Probability of Survival at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.9'}, {'value': '1.0', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.9'}, {'value': '1.0', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '0.6', 'groupId': 'OG005', 'lowerLimit': '0.4', 'upperLimit': '0.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose to 6 months after first dose.', 'description': 'Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of Time to Tumor Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'comment': 'insufficient data to calculate', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '45.1', 'comment': 'insufficient data to calculate', 'groupId': 'OG004', 'lowerLimit': '15.2', 'upperLimit': 'NA'}, {'value': '1.7', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose of test article until the first date on which disease progression or death was documented, any of which could be reported up to 5 years post last dose.', 'description': 'TTP is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>= 50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determine TTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of the Probability of Being Event Free at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.8'}, {'value': '1.0', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.9'}, {'value': '1.0', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '0.9'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to up to 6 months from 1st dose.', 'description': 'Time-to-Tumor Progression (TTP): is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>=50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determineTTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (CR+CRu+PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}, {'id': 'OG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient data to calculate', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '43.2', 'comment': 'insufficient data to calculate', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': 'NA'}, {'value': '3.9', 'comment': 'insufficient data to calculate', 'groupId': 'OG005', 'lowerLimit': '2.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from date measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the first date relapsed disease or date of death (whichever occurs first) is objectively documented.', 'description': 'Time from date measurement criteria met for CR, CRu, or PR (whichever occurred first) until first date relapsed disease/date of death. CR: Complete disappearance of all detectable clinical, radiographic evidence of disease, disease-related symptoms, normalization of NHL assignable biochemical abnormalities; lymph nodes, nodal masses regressed to normal size; spleen size regressed, not palpable on physical exam, size of other organs enlarged due to disease. CRu: CR but allows for: residual lymph node mass \\>1.5 cm in greatest transverse diameter that regressed \\>75% in product diameter. Individual nodes previously confluent, regressed by \\>75% in their product diameters; Indeterminate bone marrow. PR: ≥50% decrease in SPD of 6 largest dominant nodes/nodal masses; No increase in size of other nodes, liver, or spleen; Splenic/hepatic nodules regressed by ≥50% in SPD; Except splenic/hepatic nodules, involvement of other organs assessable and no measurable disease present.', 'unitOfMeasure': 'Month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Calculated using Kaplan-Meier method using the number of participants that responded.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36030', 'spread': '34', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40550', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 30 and 58 were measured. AUCinf of inotuzumab ozogamicin was reported. AUCinf: AUClast (area under the serum concentration-time profile for inotuzumab ozogamicin from time zero to the time of the last quantifiable concentration) +(Clast \\[last quantifiable concentration\\]/kel \\[elimination rate constant\\]) where Clast is the predicted serum concentration of inotuzumab ozogamicin at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng.hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'AUClast of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6157', 'spread': '190', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9664', 'spread': '76191', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17320', 'spread': '225', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUC of inotuzumab ozogamicin was reported. AUClast is area under the serum concentration-time profile from time zero to the time of the Clast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: all participants dosed with inotuzumab ozogamicin.'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Serum Concentration in a Dosing Interval (Tlast) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '192'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '647'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '647'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 was reported. Tlast: Time of last quantifiable concentration of inotuzumab ozogamicin. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18660', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35900', 'spread': '28', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38820', 'spread': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Steady-state serum concentrations of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUCtau of inotuzumab ozogamicin was reported. AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng.hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Peak Serum Concentration (Cmax) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '600.2', 'spread': '42', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '378.3', 'spread': '6435', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '519.2', 'spread': '586', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 were measured. Cmax of inotuzumab ozogamicin was reported. Cmax was observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Concentration (Tmax) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '192'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.583', 'upperLimit': '479'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '647'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Average Serum Concentration at Steady State (Cav) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.43', 'spread': '28', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.77', 'spread': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau (Area under the concentration time profile)/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001196', 'spread': '384', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Serum Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Cycle 2 Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09855', 'spread': '33', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08743', 'spread': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance is defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Steady-state Volume of Distribution (Vss) of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab MTD+Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.860', 'spread': '37', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.183', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss of inotuzumab ozogamicin on Dosing Days 30 and 58 were reported. Vss=CL\\*MRT (mean residence time). Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'MRT of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.31', 'spread': '39', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.24', 'spread': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'MRT: AUMCinf/AUCinf - DOF (degrees of freedom)/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.15', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '78.4'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.00', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '57.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'AUCinf of Total Calicheamicin (Conjugated + Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8437', 'spread': '39', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10060', 'spread': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'AUClast of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1901', 'spread': '192', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6129', 'spread': '85', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6755', 'spread': '145', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'n*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '647'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '654'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '650'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) for Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3201', 'spread': '78', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7794', 'spread': '38', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9197', 'spread': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Peak Serum Concentration (Cmax) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.36', 'spread': '226', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.67', 'spread': '283', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.43', 'spread': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time of Observed Maximum Concentration (Tmax) of Total Calicheamicin (Conjugated+Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '47.5'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.583', 'upperLimit': '190'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '478'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence.\n\nStudy Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Average Serum Concentration (Cav) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.60', 'spread': '38', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.69', 'spread': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001326', 'spread': '564', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001350', 'spread': '497', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4353', 'spread': '40', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3799', 'spread': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance defined as Dose/AUCinf. Corresponds to Dosing Day 30 for Cycle 2 and dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Steady-state Volume (Vss) of Total Calicheamicin (Conjugated Plus Unconjugated) Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.95', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.81', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss: Steady-state volume of distribution CL\\*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRT) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.5', 'spread': '41', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '199.5', 'spread': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'MRT: AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Serum Decay Half-Life (t1/2) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '126.5', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '251'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '176.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '354'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pk population'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Serum Concentration-time Curve (AUClast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0009904', 'spread': '22500000', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002008', 'spread': '64300000', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005896', 'spread': '1370000000', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '674'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '648'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1060'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Peak Serum Concentration (Cmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0005608', 'spread': '121496', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001153', 'spread': '1020000', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003250', 'spread': '6780000', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time of Observed Maximum Concentration (Tmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin + Rituximab on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '0.983', 'upperLimit': '647'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '47.0'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.42', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1060'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin+Rituximab on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001588', 'spread': '1044', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001495', 'spread': '811', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83270', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93760', 'spread': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Concentration-time Curve (AUClast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25740', 'spread': '139', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61770', 'spread': '88', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72430', 'spread': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '502'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '505'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '648'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.35', 'groupId': 'OG000', 'lowerLimit': '37.8', 'upperLimit': '153'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103.5', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '172'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD+ Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40180', 'spread': '51', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80060', 'spread': '37', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91370', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Peak Concentration (Cmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '776.6', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '700.4', 'spread': '448', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '653.0', 'spread': '625', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Concentration (Tmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.58'}]}]}, {'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.700', 'upperLimit': '146'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.79', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '478'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Average Serum Concentration (Cav) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119.2', 'spread': '37', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '136', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001190', 'spread': '366', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04240', 'spread': '41', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03699', 'spread': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK populatoin'}, {'type': 'SECONDARY', 'title': 'Steady-state Volume (Vss) of Inotuzumab Ozogamicin Antibody Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}], 'classes': [{'title': 'Dosing Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.283', 'spread': '29', 'groupId': 'OG000'}]}]}, {'title': 'Dosing Day 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.952', 'spread': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss: Steady-state volume of distribution CL\\*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'FG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'FG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'FG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the maximum tolerated dose (MTD) determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'FG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with diffuse large B-cell lymphoma (DLBCL) received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'FG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': "Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with either refractory aggressive or intermediate B-cell non-Hodgkin's lymphoma (NHL) received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'comment': '1 participant received rituximab only, and did not receive inotuzumab ozogamicin', 'groupId': 'FG004', 'numSubjects': '40'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other - Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other - site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A Open-Label, Phase 1/2 Study of CMC-544 (Inotuzumab Ozogamicin) in Combination With Rituximab in Subjects', 'preAssignmentDetails': 'Eligible Subjects were Randomly Assigned to Study Treatments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG001', 'title': 'INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG002', 'title': 'INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2', 'description': 'Participants received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\\^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG003', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG004', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG005', 'title': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)', 'description': 'Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m\\^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m\\^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '61.7', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '67.2', 'spread': '13.0', 'groupId': 'BG004'}, {'value': '55.5', 'spread': '15.8', 'groupId': 'BG005'}, {'value': '62.1', 'spread': '13.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population: All participants enrolled into the intended dose scheme.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'dispFirstSubmitDate': '2015-07-21', 'completionDateStruct': {'date': '2014-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2006-03-02', 'dispFirstSubmitQcDate': '2015-07-21', 'resultsFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2006-03-02', 'dispFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-06', 'studyFirstPostDateStruct': {'date': '2006-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 )', 'timeFrame': 'First 28-day cycle', 'description': 'Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered MTD. The worldwide medical monitor and investigators reviewed all significant study drug-related toxicities to determine if the dose escalation rules were satisfied and whether the dose escalation schedule required modification.'}, {'measure': 'Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)', 'timeFrame': 'Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.', 'description': 'A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)', 'timeFrame': 'Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose', 'description': 'CR: a. Complete disappearance of all detectable clinical and radiographic evidence of disease, disease-related symptoms, and normalization of NHL assignable biochemical abnormalities ; b. lymph nodes and nodal masses must have regressed to normal size; c. Spleen regressed in size and not palpable on physical exam, size of other organs enlarged due to disease decreased in size; d. Repeat bone marrow infiltrate clear. CRu: CR but allows for a. Residual lymph node mass \\>1.5 cm in greatest transverse diameter has regressed by more than 75% in diameter. Individual nodes that were previously confluent regressed more than 75 % in their product diameters; b. Indeterminate bone marrow. PR: a. ≥50 % decrease in product of the diameters (SPD) of the 6 largest dominant nodes or nodal masses; b. No increase in size of other nodes, liver, or spleen, c. Liver or spleen nodules regressed ≥50% in the SPD; d. Other organs usually assessable, no measurable disease present.'}, {'measure': 'Kaplan-Meier Estimates of Progression Free Survival (PFS)', 'timeFrame': 'From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose', 'description': 'The Kaplan-Meier method was used to determine PFS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>= 50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver.'}, {'measure': 'Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months', 'timeFrame': 'From the first dose to 6 months after first dose', 'description': 'Progression Free Survival is defined as the time interval from the first dose of test article until the first date on which relapsed disease, progression, initiation of new anti-cancer treatment due to persistent/refractory disease, or death was documented, censored at the last tumor evaluation.'}, {'measure': 'Kaplan-Meier Estimates of Overall Survival (OS)', 'timeFrame': 'From the first dose up to 5 years post last dose', 'description': 'OS was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.'}, {'measure': 'Kaplan-Meier Estimates of the Probability of Survival at 6 Months', 'timeFrame': 'From the first dose to 6 months after first dose.', 'description': 'Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.'}, {'measure': 'Kaplan-Meier Estimates of Time to Tumor Progression (TTP)', 'timeFrame': 'From the date of first dose of test article until the first date on which disease progression or death was documented, any of which could be reported up to 5 years post last dose.', 'description': 'TTP is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>= 50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determine TTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.'}, {'measure': 'Kaplan-Meier Estimates of the Probability of Being Event Free at 6 Months', 'timeFrame': 'From enrollment to up to 6 months from 1st dose.', 'description': 'Time-to-Tumor Progression (TTP): is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \\>=50% in the size of previously involved sites, c. \\>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \\>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determineTTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.'}, {'measure': 'Duration of Response (CR+CRu+PR)', 'timeFrame': 'Time from date measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the first date relapsed disease or date of death (whichever occurs first) is objectively documented.', 'description': 'Time from date measurement criteria met for CR, CRu, or PR (whichever occurred first) until first date relapsed disease/date of death. CR: Complete disappearance of all detectable clinical, radiographic evidence of disease, disease-related symptoms, normalization of NHL assignable biochemical abnormalities; lymph nodes, nodal masses regressed to normal size; spleen size regressed, not palpable on physical exam, size of other organs enlarged due to disease. CRu: CR but allows for: residual lymph node mass \\>1.5 cm in greatest transverse diameter that regressed \\>75% in product diameter. Individual nodes previously confluent, regressed by \\>75% in their product diameters; Indeterminate bone marrow. PR: ≥50% decrease in SPD of 6 largest dominant nodes/nodal masses; No increase in size of other nodes, liver, or spleen; Splenic/hepatic nodules regressed by ≥50% in SPD; Except splenic/hepatic nodules, involvement of other organs assessable and no measurable disease present.'}, {'measure': 'Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 30 and 58 were measured. AUCinf of inotuzumab ozogamicin was reported. AUCinf: AUClast (area under the serum concentration-time profile for inotuzumab ozogamicin from time zero to the time of the last quantifiable concentration) +(Clast \\[last quantifiable concentration\\]/kel \\[elimination rate constant\\]) where Clast is the predicted serum concentration of inotuzumab ozogamicin at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'AUClast of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUC of inotuzumab ozogamicin was reported. AUClast is area under the serum concentration-time profile from time zero to the time of the Clast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of the Last Quantifiable Serum Concentration in a Dosing Interval (Tlast) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 was reported. Tlast: Time of last quantifiable concentration of inotuzumab ozogamicin. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Steady-state serum concentrations of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUCtau of inotuzumab ozogamicin was reported. AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Peak Serum Concentration (Cmax) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 were measured. Cmax of inotuzumab ozogamicin was reported. Cmax was observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time to Reach Maximum Concentration (Tmax) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Average Serum Concentration at Steady State (Cav) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau (Area under the concentration time profile)/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Clearance (CL) of Serum Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance is defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Steady-state Volume of Distribution (Vss) of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab MTD+Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss of inotuzumab ozogamicin on Dosing Days 30 and 58 were reported. Vss=CL\\*MRT (mean residence time). Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'MRT of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'MRT: AUMCinf/AUCinf - DOF (degrees of freedom)/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'AUCinf of Total Calicheamicin (Conjugated + Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'AUClast of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) for Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Peak Serum Concentration (Cmax) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of Observed Maximum Concentration (Tmax) of Total Calicheamicin (Conjugated+Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence.\n\nStudy Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Average Serum Concentration (Cav) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Clearance (CL) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance defined as Dose/AUCinf. Corresponds to Dosing Day 30 for Cycle 2 and dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Steady-state Volume (Vss) of Total Calicheamicin (Conjugated Plus Unconjugated) Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss: Steady-state volume of distribution CL\\*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Mean Residence Time (MRT) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'MRT: AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Serum Decay Half-Life (t1/2) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Steady-state Serum Concentration-time Curve (AUClast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Peak Serum Concentration (Cmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of Observed Maximum Concentration (Tmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin + Rituximab on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin+Rituximab on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Steady-state Concentration-time Curve (AUClast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.\n\nStudy Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD+ Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Peak Concentration (Cmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Time to Reach Maximum Concentration (Tmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58', 'timeFrame': 'Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.'}, {'measure': 'Average Serum Concentration (Cav) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Clearance (CL) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Clearance defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}, {'measure': 'Steady-state Volume (Vss) of Inotuzumab Ozogamicin Antibody Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58', 'timeFrame': 'Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85', 'description': 'Vss: Steady-state volume of distribution CL\\*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'NHL'], 'conditions': ['B-Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '23295790', 'type': 'DERIVED', 'citation': 'Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Gine E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3129K3-101&StudyName=Study%20Evaluating%20CMC-544%20Administered%20In%20Combination%20With%20Rituximab%20In%20Subjects%20With%20Non-Hodgkin%27s%20Lymphoma%20%28NHL%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \\[CMC-544\\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.\n* Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.\n* Measurable disease.\n\nExclusion Criteria:\n\n* Subjects who are candidates for other potentially curative therapies.\n* Subjects must not have received previous radioimmunotherapy.\n* Subjects who have undergone a prior bone marrow transplantation within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00299494', 'briefTitle': "Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': '3129K3-101'}, 'secondaryIdInfos': [{'id': 'B1931004', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2005-005436-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)', 'description': 'Follicular', 'interventionNames': ['Drug: inotuzumab ozogamicin', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)', 'description': 'Diffuse Large B-cell Lymphoma', 'interventionNames': ['Drug: inotuzumab ozogamicin', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)', 'description': 'Refractory Aggressive NHL', 'interventionNames': ['Drug: inotuzumab ozogamicin', 'Drug: Rituximab']}], 'interventions': [{'name': 'inotuzumab ozogamicin', 'type': 'DRUG', 'otherNames': ['CMC-544'], 'description': 'IV, 1.8 mg/m2, q4w', 'armGroupLabels': ['INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)']}, {'name': 'inotuzumab ozogamicin', 'type': 'DRUG', 'otherNames': ['CMC-544'], 'description': 'IV, 1.8 mg/m2, q4w', 'armGroupLabels': ['INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)']}, {'name': 'inotuzumab ozogamicin', 'type': 'DRUG', 'otherNames': ['CMC-544'], 'description': 'IV, 1.8 mg/m2, q4w', 'armGroupLabels': ['INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'rituximab 375 mg/m\\^2 via IV infusion on Day 1', 'armGroupLabels': ['INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)', 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)', 'INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249 - 3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham-', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'IDS Pharmacy', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham-', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94402', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Investigational Drug Service', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medical Faculty Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute-', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Rosewell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44622', 'city': 'Dover', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.52062, 'lon': -81.47401}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS - Westlake', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '4029', 'city': 'Herston', 'state': 'Brisbane, QLD', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Gent - Department of Hematology', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '78157', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Hôpital André MIGNOT', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CH Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Shatin N.T.', 'state': 'HONG KONG', 'country': 'Hong Kong', 'facility': 'Prince Of Wales Hospital'}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Universita La Sapienza Cattedra di Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum--', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Derriford Hospital - Plymouth', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Somers Cancer Science Building MP824', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': "Bart's Cancer Institute; Queen Mary University of London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}