{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"70"},{"groupId":"OG004","value":"29"},{"groupId":"OG005","value":"27"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"3"}]}],"title":"Serious adverse event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"114"},{"groupId":"OG004","value":"41"},{"groupId":"OG005","value":"41"}],"units":"Participants"}],"description":"This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.","groups":[{"description":"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.\n\nIn the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.\n\nIn the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.","id":"OG000","title":"All Canakinumab"},{"description":"Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.","id":"OG001","title":"Canakinumab: Before Retreatment"},{"description":"Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.","id":"OG002","title":"Canakinumab: After Retreatment"},{"description":"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.\n\nReported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.","id":"OG003","title":"All Triamcinolone Acetonide"},{"description":"Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.","id":"OG004","title":"Triam: Before Switch to Canakinumab"},{"description":"Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.","id":"OG005","title":"Triam: After Switch to Canakinumab"}],"paramType":"NUMBER","populationDescription":"Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.","reportingStatus":"POSTED","timeFrame":"72 weeks","title":"Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)","type":"PRIMARY","unitOfMeasure":"participants"}