Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00822120
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
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'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C034632', 'term': 'ABVD protocol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '206-667-4623', 'title': 'Lymphoma Committee Statistician', 'organization': 'SWOG Statistical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'HIV-negative: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles', 'otherNumAtRisk': 336, 'otherNumAffected': 335, 'seriousNumAtRisk': 336, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'HIV-negative and PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles', 'otherNumAtRisk': 270, 'otherNumAffected': 268, 'seriousNumAtRisk': 270, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'HIV-negative and PET-positive: BEACOPP Escalated', 'description': 'Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles', 'otherNumAtRisk': 49, 'otherNumAffected': 49, 'seriousNumAtRisk': 49, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'HIV-positive: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'HIV-positive and PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'HIV-positive and PET-positive: BEACOPP Standard', 'description': 'Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 161}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'SVT and nodal arrhythmia - Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ocular/Visual-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dental: teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia (difficulty swallowing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastritis (including bile reflux gastritis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 173}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 191}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Chest/thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syndromes-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf (clin/microbio) w/Gr 3-4 neuts - Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap', 'description': 'HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '83'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\> 1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is 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 and progression-free are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.'}, {'type': 'PRIMARY', 'title': 'Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP', 'description': 'HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\> 1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is 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 and progression-free are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy', 'description': 'HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.'}, {'type': 'SECONDARY', 'title': 'Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET-negative: Continued ABVD After 2 Cycles of ABVD', 'description': 'Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'OG001', 'title': 'PET-positive: BEACOPP Escalated After 2 Cycles of ABVD', 'description': 'Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 months after registration', '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': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-negative: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'OG001', 'title': 'HIV-negative and PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'OG002', 'title': 'HIV-negative and PET-positive: BEACOPP Escalated', 'description': 'Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles'}], 'classes': [{'title': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, SGOT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adult respiratory distress syndrome (ARDS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, serum-low (hypoalbuminemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Arthritis (non-septic)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Carbon monoxide diffusion capacity (DL(co))', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Colitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Colitis, infectious (e.g., Clostridium difficile)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Cytokine release syndrome/acute infusion reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea (shortness of breath)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'FEV(1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, serum-high (hyperglycemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Heartburn/dyspepsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, pulmonary/upper respiratory - Nose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Blood', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Colon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Lung', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Meninges', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - UTI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Vagina', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Catheter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Lung', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Infection with normal ANC or Grade 1 or 2 neutroph', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Lung (pneumonia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Left ventricular systolic dysfunction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Metabolic/Laboratory-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - agitation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - body/general', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal/Soft Tissue-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Osteonecrosis (avascular necrosis)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Abdomen NOS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Back', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Bone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Cardiac/heart', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest wall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Chest/thorax NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Extremity-limb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Head/headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Joint', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Muscle', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Oral cavity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Stomach', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Throat/pharynx/larynx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Tumor pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatic endocrine: glucose intolerance', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphate, serum-low (hypophosphatemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis/pulmonary infiltrates', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-high (hyperkalemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, serum-low (hypokalemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Rash/desquamation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rigors/chills', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, serum-low (hyponatremia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Syncope (fainting)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight gain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients 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': 'Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap', 'description': 'HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\>1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is 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 and progression-free are censored at date of last contact.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.'}, {'type': 'SECONDARY', 'title': 'Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap', 'description': 'HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.'}, {'type': 'SECONDARY', 'title': 'Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET-negative: Continued ABVD After 2 Cycles of ABVD', 'description': 'Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'OG001', 'title': 'PET-positive: BEACOPP Standard After 2 Cycles of ABVD', 'description': 'Initial ABVD: Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles standard BEACOPP: Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles'}], 'classes': [{'categories': [{'title': 'Complete Response', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Partial Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 months after registration', '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 HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.'}, {'type': 'SECONDARY', 'title': 'Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'OG001', 'title': 'PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'OG002', 'title': 'PET-positive: BEACOPP Standard', 'description': 'Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles'}], 'classes': [{'title': 'Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Lung', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infection with unknown ANC - Urinary tract NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - agitation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mood alteration - anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - body/general', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Bone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain - Joint', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphate, serum-low (hypophosphatemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, serum-low (hyponatremia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', '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 HIV-positive 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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV-negative: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'FG001', 'title': 'HIV-positive: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'FG002', 'title': 'HIV-negative and PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'FG003', 'title': 'HIV-negative and PET-positive: BEACOPP Escalated', 'description': 'Etoposide 200 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles'}, {'id': 'FG004', 'title': 'HIV-positive and PET-negative: Continued ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 4 cycles'}, {'id': 'FG005', 'title': 'HIV-positive and PET-positive: BEACOPP Standard', 'description': 'Etoposide 100 mg/m\\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\\^2 IV Day 1, Cyclophosphamide 650 mg/m\\^2 IV Day 1, Procarbzine 100 mg/m\\^2 PO Days 1-7, Prednisone 40 mg/m\\^2 PO Days 1-14, Bleomycin 10u/m\\^2 IV Day 8, Vincristine 1.4 mg/m\\^2 IV Day 8, Q 21 Days x 6 cycles'}], 'periods': [{'title': 'Initial Registration', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Eligible and Evaluable Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Refusal Unrelated to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Reasons not Protocol Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'PET-directed Therapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '270'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Eligibile and Evaluable Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '270'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '270'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Refusal Unrelated to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV-negative: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'BG001', 'title': 'HIV-positive: Initial ABVD', 'description': 'Doxorubicin 25 mg/m\\^2 IV, Bleomycin 10u/m\\^2 IV, Vinblastine 6mg/m\\^2 IV, Dacarbazine 375 mg/m\\^2 IV Days 1,15 Q 28 Days x 2 cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '44.6', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '50'}, {'value': '32.4', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only eligible and evaluable HIV-positive patients were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2009-01-13', 'resultsFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-06', 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\> 1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is 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 and progression-free are censored at date of last contact.'}, {'measure': 'Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\> 1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is 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 and progression-free are censored at date of last contact.'}], 'secondaryOutcomes': [{'measure': 'Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging', 'timeFrame': '2 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.'}, {'measure': 'Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD', 'timeFrame': '7 months after registration', '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': 'Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'timeFrame': 'Up to 1 year', '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': 'Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.', 'timeFrame': '2 years', 'description': 'Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \\>= 50% increase in greatest transverse diameter (GTD) of any nodal \\> 1 cm in shortest axis, or \\>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \\>1.5 cm or if both long and short axes are \\> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is 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 and progression-free are censored at date of last contact.'}, {'measure': 'Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.', 'timeFrame': '5 years', 'description': 'Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.'}, {'measure': 'Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD', 'timeFrame': '7 months after registration', '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': 'Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'timeFrame': 'Up to 1 year', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage III adult Hodgkin lymphoma', 'stage IV adult Hodgkin lymphoma', 'adult lymphocyte depletion Hodgkin lymphoma', 'adult lymphocyte predominant Hodgkin lymphoma', 'adult mixed cellularity Hodgkin lymphoma', 'adult nodular sclerosis Hodgkin lymphoma', 'HIV infection'], 'conditions': ['Lymphoma', 'Nonneoplastic Condition']}, 'referencesModule': {'references': [{'pmid': '40135712', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.'}, {'pmid': '31331918', 'type': 'DERIVED', 'citation': 'Stephens DM, Li H, Schoder H, Straus DJ, Moskowitz CH, LeBlanc M, Rimsza LM, Bartlett NL, Evens AM, LaCasce AS, Barr PM, Knopp MV, Hsi ED, Leonard JP, Kahl BS, Smith SM, Friedberg JW. Five-year follow-up of SWOG S0816: limitations and values of a PET-adapted approach with stage III/IV Hodgkin lymphoma. Blood. 2019 Oct 10;134(15):1238-1246. doi: 10.1182/blood.2019000719.'}, {'pmid': '30723079', 'type': 'DERIVED', 'citation': 'Hsi ED, Li H, Nixon AB, Schoder H, Bartlett NL, LeBlanc M, Smith S, Kahl BS, Leonard JP, Evens AM, Scott DW, Rimsza LM, Friedberg JW. Serum levels of TARC, MDC, IL-10, and soluble CD163 in Hodgkin lymphoma: a SWOG S0816 correlative study. Blood. 2019 Apr 18;133(16):1762-1765. doi: 10.1182/blood-2018-08-870915. Epub 2019 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.\n\nPURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).\n* To estimate the 2-year PFS of patients who are PET-positive after treatment with 2 courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride, and prednisone (BEACOPP).\n\nSecondary\n\n* To estimate the 2-year overall survival (OS) of patients treated with these regimens.\n* To estimate the response rate (i.e., complete and partial responses) in patients treated with these regimens.\n* To evaluate the toxicity of these response-adapted regimens.\n* To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies.\n* To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of HIV-positive patients treated with these response-adapted regimens.\n\nOUTLINE: This is a multicenter study.\n\nAll patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens:\n\n* Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n* Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nSix to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan.\n\nSome patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy.\n\nAfter completion of study treatment, patients are followed up periodically for 7 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)\n\n * Previously untreated stage III or IV disease\n * No nodular lymphocyte predominant disease\n* Bidimensionally measurable disease\n* Adequate biopsy samples from original diagnostic specimen must be available for pathologic review\n\n * Tissue obtained from core biopsies allowed\n * No tissue obtained from needle aspirations or cytologies\n* Must have known HIV status\n\n * No multi-drug resistant HIV infection, CD4 counts \\< 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients\n * HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count \\> 250/μL at any time within 8 months prior to HL diagnosis allowed\n* Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days\n* Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days\n\n * Combined PET/CT scans required\n * No older "stand-alone" FDG-PET scans\n * No low-resolution "localization" CT scans as part of a combined PET/CT scans\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin, albumin, white blood cell count (WBC), and lymphocytes measured within the past 28 days\n* Serum estradiol (women only), testosterone (men only), follicle stimulating hormone (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60 days prior to registration\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy\n* No significant cardiac abnormalities as assessed by multiple gated acquisition scan (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms\n* Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)\n\n * Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible\n* Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)\n* No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (DLCO) \\> 25% below predicted after correction for hemoglobin) unless attributable to lymphoma\n* No requirement for continuous supplemental oxygen therapy\n* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma\n* No prior solid organ transplantation'}, 'identificationModule': {'nctId': 'NCT00822120', 'briefTitle': 'S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging', 'orgStudyIdInfo': {'id': 'CDR0000630501'}, 'secondaryIdInfos': [{'id': 'S0816', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV Positive, PET Positive: BEACOPP standard', 'description': 'Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles', 'interventionNames': ['Biological: bleomycin sulfate', 'Drug: BEACOPP regimen', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: prednisone', 'Drug: procarbazine hydrochloride', 'Drug: vincristine sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'HIV Negative, PET Positive: BEACOPP escalated', 'description': 'Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles', 'interventionNames': ['Biological: bleomycin sulfate', 'Biological: filgrastim', 'Drug: BEACOPP regimen', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: prednisone', 'Drug: procarbazine hydrochloride', 'Drug: vincristine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV Positive, PET Negative: ABVD', 'description': 'Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2', 'interventionNames': ['Biological: bleomycin sulfate', 'Drug: ABVD regimen', 'Drug: dacarbazine', 'Drug: doxorubicin hydrochloride', 'Drug: vinblastine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV Negative, PET Negative: ABVD', 'description': 'Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2', 'interventionNames': ['Biological: bleomycin sulfate', 'Drug: ABVD regimen', 'Drug: dacarbazine', 'Drug: doxorubicin hydrochloride', 'Drug: vinblastine sulfate']}], 'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL', 'armGroupLabels': ['HIV Negative, PET Negative: ABVD', 'HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Negative: ABVD', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated']}, {'name': 'ABVD regimen', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Negative: ABVD', 'HIV Positive, PET Negative: ABVD']}, {'name': 'BEACOPP regimen', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'dacarbazine', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Negative: ABVD', 'HIV Positive, PET Negative: ABVD']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Negative: ABVD', 'HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Negative: ABVD', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'etoposide', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'prednisone', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'procarbazine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}, {'name': 'vinblastine sulfate', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Negative: ABVD', 'HIV Positive, PET Negative: ABVD']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['HIV Negative, PET Positive: BEACOPP escalated', 'HIV Positive, PET Positive: BEACOPP standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University Medical Center North', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group - Springdale', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92807', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Anaheim/Orange County', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Deer Valley', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '91706', 'city': 'Baldwin Park', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Baldwin Park', 'geoPoint': {'lat': 34.08529, 'lon': -117.9609}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Bellflower', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, 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'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Group', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Redwood City', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94801', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Richmond', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Riverside', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95661', 'city': 'Roseville', 'state': 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