{"analyses":[{"groupDescription":"Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.927","pValueComment":"P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model","statisticalMethod":"Poisson regression model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"23"}]}],"title":"Grade 2 or Higher Leukopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"Grade 2 or Higher Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"16"}]}],"title":"Grade 3 or Higher Infections"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"Hemorrhagic Cystitis (Grade 2 or Lower)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"title":"Malignancy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"}]}],"title":"Venous Thromboembolic Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"7"}]}],"title":"Hospitalization Resulting from the Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Cerebrovascular Accident (CVA)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Infusion Reactions Leading to Infusion Disc."}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident","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":"Safety Sample","reportingStatus":"POSTED","timeFrame":"Through common close-out (defined as 18 months after the last participant is enrolled in the trial)","title":"Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy","type":"SECONDARY","unitOfMeasure":"participants"}