{"analyses":[{"ciPctValue":"95","groupDescription":"Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.504","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"37"}]}],"title":"# Participants with at least one SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"}]}],"title":"Blood and Lymphatic System Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"Cardiac Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Eye Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"Gastrointestinal Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}],"title":"General Disorders and Administration Site"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"Immune System Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"title":"Infections and Infestations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Injury, Poisoning, and Procedural Complications"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Investigations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"Metabolism and Nutrition Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Musculoskeletal and Connective Tissue Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Neoplasms Benign, Malignant, and Unspecified"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Nervous System Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Pregnancy, Puerperium, and Perinatal Conditions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Psychiatric Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"}]}],"title":"Renal and Urinary Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"title":"Respiratory, Thoracic, and Mediastinal Disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"title":"Vascular Disorders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.","groups":[{"description":"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled \"Detailed Description\" for additional treatment information.","id":"OG000","title":"Rituximab"},{"description":"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled \"Detailed Description\" for additional treatment information.","id":"OG001","title":"Control Group"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat","reportingStatus":"POSTED","timeFrame":"Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)","title":"Number of Subjects Experiencing Serious Adverse Events","type":"POST_HOC","unitOfMeasure":"participants"}