{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"}]}],"title":"Incidence of grade ≥ 3 stomatitis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"34"}]}],"title":"No incidence of grade ≥ 3 stomatitis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences","groups":[{"description":"Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.","id":"OG000","title":"Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)"},{"description":"Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.","id":"OG001","title":"Group C (Chemotherapy, Monoclonal Antibody Therapy)"}],"paramType":"NUMBER","populationDescription":"Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.","reportingStatus":"POSTED","timeFrame":"Up to 1 year","title":"Grade ≥ 3 Stomatitis","type":"PRIMARY","unitOfMeasure":"participants"}