{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.\n\nMethotrexate: 6000 mg/m\\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.\n\nRituximab: 375 mg/m\\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate\n\nLeucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes","id":"OG000","title":"Rituximab, High-Dose Methotrexate & Leucovorin Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 142 months and 11 days.","title":"Number of Participants With Serious and Non-serious Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}