{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"15"}]}],"title":"IRRs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"9"}]}],"title":"Grade 3-5 infection"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Any Hepatitis B reactivation and PML"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"5"}]}],"title":"Drug related Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Drug related Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Gastrointestinal Perforations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Worsening of pre-existing Cardiac Conditions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Hy's Law"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Suspected Transmission of an Infectious Agent by the Study Drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in participant administered a pharmaceutical product \\& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable \\& unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \\& aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions","groups":[{"description":"Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.","id":"OG000","title":"Obinutuzumab"},{"description":"Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety evaluable population included all participants who received any part of blinded infusion of obinutuzumab or placebo and were grouped according to the treatment they actually received rather than the treatment assigned. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups.","reportingStatus":"POSTED","timeFrame":"Up to Week 76","title":"Number of Participants With Adverse Events of Special Interest (AESIs)","type":"SECONDARY","unitOfMeasure":"Participants"}