{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Hyperglycemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Transaminase alone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Mucositis/stomatitis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Nausea/vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Hyperbilirubinemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Fever w/o neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Hypocalcemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Elevated INR/Prothrombin time"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Renal Failure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Esophagitis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"}],"units":"Participants"}],"description":"Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy","groups":[{"description":"Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.","id":"OG000","title":"HD Chemo and Auto Stem Cells"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From date of randomization until death of any cause, assessed up to 12 weeks","title":"Toxic Effects","type":"PRIMARY","unitOfMeasure":"participants"}