{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"}]}],"title":"grade 3,4 neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"grade 3, 4 leukopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"grade 3, 4 anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"grade 3, 4 thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"grade 3, 4 lymphopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"grade 3, 4 febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"grade 3, 4 diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"grade 3, 4 Peripheral sensory neuropathy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 anorexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 mucositis oral"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 Rash maculo-papular"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 hypotension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"grade 3, 4 back pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.\n\n39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.","groups":[{"description":"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:\n\nTRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.\n\nMAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant","id":"OG000","title":"Treatment (Combination Chemotherapy, Lenalidomide)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety data for the Intent to treat (ITT) group of subjects.","reportingStatus":"POSTED","timeFrame":"Up to 1 year","title":"Number of Participants With Adverse Events Graded According to CTC (Phase II)","type":"SECONDARY","unitOfMeasure":"Participants"}