{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"}]}],"title":"TLS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"}]}],"title":"IRRs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"194"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. TLS and IRRs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening; Grade 5 = Death. A higher grade indicates a worse outcome.","groups":[{"description":"Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\\^2 on Day 1 of Cycles 2-6.","id":"OG000","title":"Bendamustine + Rituximab Main Study"},{"description":"Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\\^2 on Day 1 of Cycles 2-6.","id":"OG001","title":"Venetoclax + Rituximab Main Study"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.","reportingStatus":"POSTED","timeFrame":"From signing of informed consent form up to approximately 8 years 5 months","title":"Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs)","type":"SECONDARY","unitOfMeasure":"Participants"}