{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"60"},{"groupId":"OG004","value":"20"},{"groupId":"OG005","value":"19"}]}],"title":"Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"}]}],"title":"Serious Adverse Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"115"},{"groupId":"OG004","value":"39"},{"groupId":"OG005","value":"39"}],"units":"Participants"}],"description":"This was the primary endpoint of both extension studies. Adverse event is 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":"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients 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. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.\n\nAfter completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label \"on demand\" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study.","id":"OG000","title":"All Randomized to Canakinumab"},{"description":"All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab","id":"OG001","title":"Randomized to Canakinumab :Before Re-treated With Canakinumab"},{"description":"All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab","id":"OG002","title":"Randomized to Canakinumab :After Re-treated With Canakinumab"},{"description":"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients 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. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.\n\nPatients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab","id":"OG003","title":"Randomized to Triamcinolone Acetonide (Triam)"},{"description":"All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab","id":"OG004","title":"Randomized to Triam: Before Switched to Canakinumab"},{"description":"All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab","id":"OG005","title":"Randomized to Triam: After Switched 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 overall","title":"Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)","type":"PRIMARY","unitOfMeasure":"Participants"}