{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"}],"units":"Participants"}],"description":"Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.","groups":[{"description":"Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.","id":"OG000","title":"Group 1 (Identified by Central Review as High Risk)"}],"paramType":"NUMBER","populationDescription":"Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332.","reportingStatus":"POSTED","timeFrame":"During planned six cycles of chemotherapy","title":"Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0","type":"SECONDARY","unitOfMeasure":"participants"}