{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"376.32","upperLimit":"411.80","value":"393.76"},{"groupId":"OG001","lowerLimit":"270.66","upperLimit":"302.34","value":"286.17"},{"groupId":"OG002","lowerLimit":"244.78","upperLimit":"276.22","value":"260.14"},{"groupId":"OG003","lowerLimit":"234.36","upperLimit":"266.07","value":"249.84"},{"groupId":"OG004","lowerLimit":"201.62","upperLimit":"222.86","value":"212.04"}]}],"title":"Total AE rate"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.59","upperLimit":"16.11","value":"12.54"},{"groupId":"OG001","lowerLimit":"9.91","upperLimit":"16.87","value":"13.05"},{"groupId":"OG002","lowerLimit":"14.79","upperLimit":"23.42","value":"18.74"},{"groupId":"OG003","lowerLimit":"9.34","upperLimit":"16.69","value":"12.62"},{"groupId":"OG004","lowerLimit":"10.62","upperLimit":"16.02","value":"13.12"}]}],"title":"Total SAE rate"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.33","upperLimit":"7.59","value":"5.14"},{"groupId":"OG001","lowerLimit":"2.23","upperLimit":"6.12","value":"3.82"},{"groupId":"OG002","lowerLimit":"3.36","upperLimit":"8.11","value":"5.35"},{"groupId":"OG003","lowerLimit":"0.89","upperLimit":"4.06","value":"2.06"},{"groupId":"OG004","lowerLimit":"2.99","upperLimit":"6.17","value":"4.37"}]}],"title":"Rate for AEs leading to withdrawal"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.57","upperLimit":"101.92","value":"92.94"},{"groupId":"OG001","lowerLimit":"79.03","upperLimit":"96.66","value":"87.52"},{"groupId":"OG002","lowerLimit":"78.56","upperLimit":"96.88","value":"87.36"},{"groupId":"OG003","lowerLimit":"78.27","upperLimit":"97.12","value":"87.32"},{"groupId":"OG004","lowerLimit":"66.77","upperLimit":"79.27","value":"72.82"}]}],"title":"AESI All Infections"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.88","upperLimit":"5.34","value":"3.29"},{"groupId":"OG001","lowerLimit":"1.24","upperLimit":"4.43","value":"2.47"},{"groupId":"OG002","lowerLimit":"3.55","upperLimit":"8.40","value":"5.60"},{"groupId":"OG003","lowerLimit":"1.78","upperLimit":"5.73","value":"3.35"},{"groupId":"OG004","lowerLimit":"2.32","upperLimit":"5.20","value":"3.55"}]}],"title":"AESI Serious Infections"},{"categories":[{"measurements":[{"comment":"There were no opportunistic infections in this period.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"1.25","value":"0.22"},{"comment":"There were no opportunistic infections in this period.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG003","lowerLimit":"0.06","upperLimit":"1.86","value":"0.52"},{"groupId":"OG004","lowerLimit":"0.03","upperLimit":"0.99","value":"0.27"}]}],"title":"AESI Opportunistic infections"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.90","upperLimit":"32.41","value":"27.35"},{"groupId":"OG001","lowerLimit":"7.19","upperLimit":"13.29","value":"9.90"},{"groupId":"OG002","lowerLimit":"3.36","upperLimit":"8.11","value":"5.35"},{"groupId":"OG003","lowerLimit":"2.16","upperLimit":"6.37","value":"3.86"},{"groupId":"OG004","lowerLimit":"2.77","upperLimit":"5.85","value":"4.10"}]}],"title":"AESI Hypersensitivity events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.05","upperLimit":"1.49","value":"0.41"},{"groupId":"OG001","lowerLimit":"0.25","upperLimit":"2.30","value":"0.90"},{"groupId":"OG002","lowerLimit":"0.06","upperLimit":"1.76","value":"0.49"},{"groupId":"OG003","lowerLimit":"0.28","upperLimit":"2.64","value":"1.03"},{"groupId":"OG004","lowerLimit":"0.22","upperLimit":"1.59","value":"0.68"}]}],"title":"AESI Hepatic events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.13","upperLimit":"1.80","value":"0.62"},{"comment":"There were no myocardial infarctions in this period.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG002","lowerLimit":"0.01","upperLimit":"1.36","value":"0.24"},{"groupId":"OG003","lowerLimit":"0.16","upperLimit":"2.26","value":"0.77"},{"groupId":"OG004","lowerLimit":"0.03","upperLimit":"0.99","value":"0.27"}]}],"title":"AESI Myocardial infarction"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.01","upperLimit":"1.15","value":"0.21"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"1.25","value":"0.22"},{"groupId":"OG002","lowerLimit":"0.15","upperLimit":"2.13","value":"0.73"},{"groupId":"OG003","lowerLimit":"0.01","upperLimit":"1.44","value":"0.26"},{"groupId":"OG004","lowerLimit":"0.08","upperLimit":"1.20","value":"0.41"}]}],"title":"AESI Stroke, ischemic or hemorrhagic"},{"categories":[{"measurements":[{"comment":"There were no medically confirmed GI perforations in this period.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"comment":"There were no medically confirmed GI perforations in this period.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG002","lowerLimit":"0.06","upperLimit":"1.76","value":"0.49"},{"groupId":"OG003","lowerLimit":"0.01","upperLimit":"1.44","value":"0.26"},{"comment":"There were no medically confirmed GI perforations in this period.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}],"title":"AESI GI perforation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.45","upperLimit":"2.69","value":"1.23"},{"groupId":"OG001","lowerLimit":"0.78","upperLimit":"3.55","value":"1.80"},{"groupId":"OG002","lowerLimit":"0.27","upperLimit":"2.49","value":"0.97"},{"groupId":"OG003","lowerLimit":"0.16","upperLimit":"2.26","value":"0.77"},{"groupId":"OG004","lowerLimit":"0.75","upperLimit":"2.69","value":"1.50"}]}],"title":"AESI Malignancy"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.01","upperLimit":"1.15","value":"0.21"},{"comment":"There were no demyelinating disorders in this period.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"comment":"There were no demyelinating disorders in this period.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"comment":"There were no demyelinating disorders in this period.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"comment":"There were no demyelinating disorders in this period.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}],"title":"AESI Demyelinating disorders"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.13","upperLimit":"1.80","value":"0.62"},{"groupId":"OG001","lowerLimit":"0.05","upperLimit":"1.63","value":"0.45"},{"groupId":"OG002","lowerLimit":"0.06","upperLimit":"1.76","value":"0.49"},{"groupId":"OG003","lowerLimit":"0.01","upperLimit":"1.44","value":"0.26"},{"groupId":"OG004","lowerLimit":"0.22","upperLimit":"1.59","value":"0.68"}]}],"title":"AESI Serious bleeding disorders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"538"},{"groupId":"OG001","value":"509"},{"groupId":"OG002","value":"463"},{"groupId":"OG003","value":"434"},{"groupId":"OG004","value":"414"}],"units":"Participants"}],"description":"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.\n\nAbbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed \"unrelated\" to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.\n\nMedical confirmation of the AESI \"GI perforation\" was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).","id":"OG000","title":"Months 0 - 12"},{"description":"Participants with scores during Months 13 - 24, which equates to Weeks 49-96 (Total PY=444.49).","id":"OG001","title":"Months 13 - 24"},{"description":"Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).","id":"OG002","title":"Months 25 - 36"},{"description":"Participants with scores during Months 37 - 48, which equates to Weeks 145-192 (Total PY=388.25).","id":"OG003","title":"Months 37 - 48"},{"description":"Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).","id":"OG004","title":"Months Greater Than 48"}],"paramType":"NUMBER","populationDescription":"All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.","reportingStatus":"POSTED","timeFrame":"through 264 Weeks","title":"Summary Adverse Event Rates Over Time","type":"PRIMARY","unitOfMeasure":"Adverse Events per 100 Patient Years"}