{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.90","upperLimit":"8.17","value":"5.5"},{"groupId":"OG001","lowerLimit":"3.87","upperLimit":"9.55","value":"6.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"289"},{"groupId":"OG001","value":"298"}],"units":"Participants"}],"description":"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The \"Modified Balis scale of Pediatric Neuropathy\" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score \\>/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I (ABVE-PC)"},{"description":"Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"ARM II (Bv-AVEPC)"}],"paramType":"NUMBER","populationDescription":"All the eligible patients who had undergone randomization","reportingStatus":"POSTED","timeFrame":"From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.","title":"Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale","type":"SECONDARY","unitOfMeasure":"Percentage of patients"}