Viewing Study NCT01359592

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Ignite Creation Date: 2025-12-24 @ 3:24 PM
Ignite Modification Date: 2025-12-28 @ 7:40 PM
Study NCT ID: NCT01359592
Status: COMPLETED
Last Update Posted: 2025-06-17
First Post: 2011-05-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D050486', 'term': 'Serotonin Plasma Membrane Transport Proteins'}, {'id': 'C422802', 'term': 'ibritumomab tiuxetan'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D027981', 'term': 'Symporters'}, {'id': 'D016623', 'term': 'Ion Pumps'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D050480', 'term': 'Plasma Membrane Neurotransmitter Transport Proteins'}, {'id': 'D050479', 'term': 'Neurotransmitter Transport Proteins'}, {'id': 'D000070590', 'term': 'Solute Carrier Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lymph@crab.org', 'phone': '206-667-4623', 'title': 'Lymphoma Committee Statistician', 'organization': 'SWOG Statistics and Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 4 months or time of disease progression', 'description': 'The total number or participants at risk in this section is the number or participants in each arm that are eligible and evaluable.', 'eventGroups': [{'id': 'EG000', 'title': 'R-CHOP x 3', 'description': 'Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 130, 'seriousNumAtRisk': 132, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'R-CHOP x 6', 'description': 'Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PET-negative: R-CHOP x 1', 'description': 'Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP\n\nR-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5 2', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 105, 'seriousNumAtRisk': 113, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®)', 'description': 'Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.\n\nRadiation Therapy included:\n\nIFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRadioimmunotherapy included:\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoidal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periorbital edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 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and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 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'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Resp, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R-CHOP x 3 Followed by PET-directed Therapy', 'description': 'R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nPET-directed therapy included:\n\nPET-negative: R-CHOP x 1 PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan\n\nR-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nIFRT + Yttrium-90 ibritumomab tiuxetan included:\n\nIFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.\n\nProgressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \\>1.5 cm in the longest axis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interim PET-negative', 'description': 'Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored.\n\nNegative:\n\n1. no uptake\n2. uptake ≤ mediastinum\n3. uptake \\> mediastinum but ≤ liver'}, {'id': 'OG001', 'title': 'Interim PET-positive', 'description': 'Interim PET/CT scan was performed on Day 15-18 of Cycle 3 of R-CHOP chemotherapy. PET/CT scans were centrally reviewed and scored.\n\nPositive:\n\n4 uptake \\> liver in some sites even if uptake ≤ liver or mediastinum at other sites 5 uptake \\> liver in over 90% of sites or development of new uptake consistent with progressive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '94'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients who had interim PET/CT performed were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'R-CHOP x 3', 'description': 'Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'OG001', 'title': 'R-CHOP x 6', 'description': 'Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'OG002', 'title': 'PET-negative: R-CHOP x 1', 'description': 'Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP\n\nR-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'OG003', 'title': 'PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®', 'description': 'Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.\n\nRadiation Therapy included:\n\nIFRT:180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRadioimmunotherapy included:\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9'}], 'classes': [{'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bone pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CD4 lymphocytes decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Catheter related infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Edema limbs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Endocrine disorders - Other, specify', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Generalized muscle weakness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Leukemia secondary to oncology chemotherapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lung infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Nervous system disorders - Other, specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Peripheral sensory neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Resp, thoracic and mediastinal disorders - Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Skin infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Thromboembolic event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 months or time of disease progression.', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.'}, {'type': 'SECONDARY', 'title': 'Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R-CHOP x 3 Followed by PET-directed Therapy', 'description': 'R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nPET-directed therapy included:\n\nPET-negative: R-CHOP x 1 PET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan\n\nR-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nIFRT + Yttrium-90 ibritumomab tiuxetan included:\n\nIFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients were included in the analysis. The patient who was upstaged at baseline by PET/CT was not included.'}, {'type': 'SECONDARY', 'title': 'Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R-CHOP x 3 Followed by R-CHOP x 1 in Interim PET-negative Patients', 'description': 'R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nPET-directed therapy included:\n\nPET-negative: R-CHOP x 1\n\nR-CHOP x 1: 1 cycle of R-CHOP, 21 days/cycle\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'OG001', 'title': 'R-CHOP x 3 Followed by IFRT + Yttrium-90 Ibritumomab Tiuxetan in Interim PET-positive Patients', 'description': 'R-CHOP x 3: Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5\n\nPET-directed therapy included:\n\nPET-positive: IFRT + Yttrium-90 ibritumomab tiuxetan\n\nIFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9'}], 'classes': [{'categories': [{'title': 'Complete Response', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Partial Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Inadequate Assessment', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 months', 'description': 'Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients who treated with PET-directed therapy based on FDG-PET imaging after 3 cycles of R-CHOP were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival.', 'timeFrame': '5 years', 'description': 'Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA).\n\nData for this outcome measure is not available at this time. We expect this data to be available by December 2025.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'R-CHOP x 3', 'description': 'Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'FG001', 'title': 'R-CHOP x 6', 'description': 'Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'FG002', 'title': 'PET-negative: R-CHOP x 1', 'description': 'Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP\n\nR-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}, {'id': 'FG003', 'title': 'PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®)', 'description': 'Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed.\n\nRadiation Therapy included:\n\nIFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy\n\nRadioimmunotherapy included:\n\nRituximab: 250 mg/m\\^2 IV administration on Day 1 then 7, 8, or 9\n\nYttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9'}], 'periods': [{'title': 'Initial Registration', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Eligible and Evaluable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other reason not protocol specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'PET-Directed Therapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '137'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Eligible and Evaluable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '111'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Refusal unrelated to adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients with nonbulky (\\< 10 cm) stage I/II untreated DLBCL received 3 cycles of standard R-CHOP therapy and underwent a centrally reviewed interim PET/computed tomography scan (iPET). Those with a negative iPET proceeded with 1 additional cycle of R-CHOP, whereas those with a positive iPET received involved field radiation therapy followed by ibritumomab tiuxetan radioimmunotherapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'R-CHOP x 3', 'description': 'Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP\n\nFor each cycle, R-CHOP therapy included:\n\nRituximab: 375 mg/m\\^2 IV administration on Day 1\n\nCyclophosphamide: 750 mg/m\\^2 IV administration on Day 1\n\nDoxorubicin: 50 mg/m\\^2 IV administration on Day 1\n\nVincristine: 1.4 mg/m\\^2 (maximum 2 mg) IV administration on Day 1\n\nPrednisone: 100 mg administered orally on Days 1 through 5'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Age > 60 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Age <= 60 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Zubrod Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grade 0: Fully active; able to carry on all pre-disease activities without restriction.\n\nGrade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.\n\nGrade 2: Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.\n\nGrade 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.\n\nGrade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.', 'unitOfMeasure': 'Participants'}, {'title': 'Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Stage I', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Stage II', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ann Arbor Classification (AJCC Manual for Staging of Cancer, 7th ed., 2010)\n\nStage I: Involvement of a single lymph node region (I) or localized involvement of a single extralymphatic organ or site (IE).\n\nStage II: Involvement of two or more lymph node regions on the same side of the diaphragm (II) or localized involvement of a single associated extralymphatic organ or site and its regional lymph nodes with or without other lymph node lesions on the same side of the diaphram (IIE).', 'unitOfMeasure': 'Participants'}, {'title': 'Symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'A', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'B', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A = Asymptomatic\n\nB = Fever, sweats, weight loss \\> 10% of body weight', 'unitOfMeasure': 'Participants'}, {'title': 'Elevated Lactate Dehydrogenase (LDH)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Extranodal Involvement', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage-modified International Prognostic Index risk factors', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'One point is assigned for each of the following statements that is true:\n\n1. Age (over 60)\n2. Performance status 2\n3. LDH greater than institutional upper limit of normal\n4. Stage II Disease', 'unitOfMeasure': 'Participants'}, {'title': 'Histologic Subtype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Diffuse large B-cell lymphoma, NOS', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'High-grade B-cell lymphoma with MYC and BCL2 or/and BCL6 rearrangements', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'High-grade B-cell lymphoma, NOS', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'T cell/histiocyte-rich large B-cell lymphoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Central pathologic review not performed', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cell of Origin by Lymph2Cx', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'categories': [{'title': 'GCB', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'ABC', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unclassifiable', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'GCB: germinal center B-cell\n\nABC: activated B-cell', 'unitOfMeasure': 'Participants', 'populationDescription': 'Cell of origin by Lymph2Cx was assessable in 87 patients'}, {'title': 'Double protein expressors (DPE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}]}], 'categories': [{'title': 'DPE', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Non-DPE', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Double protein expressor (DPE) status is defined as having both positive MYC staining of at least 40% and BCL2 staining of at least 50% of malignant cells on immunohistochemistry slides', 'unitOfMeasure': 'Participants', 'populationDescription': 'Double protein expressor status was determined in 123 patients'}], 'populationDescription': 'Eligible and evaluable patients were included. The patient who was upstaged at baseline by PET/CT was not included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-10', 'size': 3631925, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-06-01T18:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2011-05-21', 'resultsFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-08', 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.\n\nProgressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \\>1.5 cm in the longest axis.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.'}, {'measure': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'timeFrame': 'up to 4 months or time of disease progression.', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.'}, {'measure': 'Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)', 'timeFrame': 'up to 5 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.'}, {'measure': 'Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP', 'timeFrame': 'Up to 4 months', 'description': 'Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.'}, {'measure': 'Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival.', 'timeFrame': '5 years', 'description': 'Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA).\n\nData for this outcome measure is not available at this time. We expect this data to be available by December 2025.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage IV adult diffuse large cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.\n\nPURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).\n\nSecondary\n\n* To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL.\n* To evaluate toxicity of the protocol treatments in this patient population.\n* To evaluate the response probability in this patient population.\n* To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.\n* To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL.\n* To describe outcomes in the subgroup of patients upstaged by PET/CT.\n* To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).\n\nChemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3\\* courses. NOTE: \\*Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.\n\nFDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.\n\nMonoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.\n\nPatients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.\n\nAfter completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)\n\n * Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group\n * Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections\n * Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible\n* Patients must have non-bulky stage I or II disease by Ann Arbor classification\n\n * This staging excludes FDG-PET evaluation\n * Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible\n* Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration\n\n * Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol\n * If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable\n* Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma\n\n * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration\n* Patients may have either measurable or evaluable limited-stage DLBCL\n\n * Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible\n * If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)\n * All measurable disease must be assessed within 28 days prior to registration\n * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration\n* Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 1,000/mm³\n* Platelet count ≥ 100,000/mm³\n* Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)\n* Patients must not be pregnant or nursing\n* Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period\n* Patients must not be known to be HIV-positive\n* No other prior malignancy is allowed except for the following:\n\n * Adequately treated basal cell or squamous cell skin cancer\n * In situ cervical cancer\n * Adequately treated stage I or II cancer from which the patient is currently in complete remission\n * Any other cancer from which the patient has been disease-free for 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma'}, 'identificationModule': {'nctId': 'NCT01359592', 'briefTitle': 'S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)', 'orgStudyIdInfo': {'id': 'CDR0000700624'}, 'secondaryIdInfos': [{'id': 'S1001', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': 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