{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"}]}],"title":"Infusion Related Reactions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"11"}]}],"title":"Grade 3 or Higher Infections"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Drug-related Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Drug-related Thrombocytopenia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"Infusion related reaction is defined as any event reported within 24 hours of infusion and thought to be causally related to the investigational agent by the investigator. Grade 3 or higher infections include all events of Grade 3 to 5 under the SOC of infections and infestations. Drug-related neutropenia is defined as events in the Roche AE Grouped Term (AEGT) \"Neutropenia and associated complications\" and thought to be causally related to the investigational agent by the investigator. Drug-related thrombocytopenia is defined as events in the Standard MedDRA Query (SMQ) \"Haematopoietic Thrombocytopenia narrow\" and thought to be causally related to the investigational agent by the investigator.","groups":[{"description":"Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.","id":"OG000","title":"OBINUTUZUMAB 1000MG and MMF"},{"description":"Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.","id":"OG001","title":"PLACEBO and MMF"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population was defined as all participants who have received any amount of study medication. Participants are reported under the therapy they actually received.","reportingStatus":"POSTED","timeFrame":"From baseline to approximately 7 years and 8 months","title":"Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia","type":"SECONDARY","unitOfMeasure":"Participants"}