{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Serious Adverse Events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.","groups":[{"description":"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5\n\nRituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.","id":"OG000","title":"Rituximab Plus Temozolomide"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"up to 4 weeks","title":"Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.","type":"SECONDARY","unitOfMeasure":"participants"}