{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"}]}],"title":"Grade 3-4 anaemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Grade 3-4 thrombocoytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Grade 3-4 febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Grade 3-4 mucositis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Grade 3-4 sepsis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Grade 3-4 increased creatinine"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Grade 3-4 liver transaminases"}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"}],"units":"Participants"}],"description":"Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly.","groups":[{"description":"Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.\n\nprednisone: Given PO\n\ncyclophosphamide: Given IV\n\netoposide: Given PO or IV\n\nvincristine sulfate: Given IV\n\npralatrexate: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\ncomparative genomic hybridization: Correlative studies\n\ngene expression analysis: Correlative studies\n\nnucleic acid sequencing: Correlative studies\n\nmutation analysis: Correlative studies","id":"OG000","title":"Treatment (Chemotherapy and Enzyme Inhibitor Therapy)"}],"paramType":"NUMBER","populationDescription":"All eligible patients who received at least one cycle of chemotherapy were evaluable for toxicity.","reportingStatus":"POSTED","timeFrame":"22 months","title":"To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}