{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.96","upperLimit":"1.45","value":"1.18"},{"groupId":"OG001","lowerLimit":"1.65","upperLimit":"2.47","value":"2.02"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.\n\nParticipants met the definition of new flare if they had:\n\n* Flare in joint, not a previously affected joint (at baseline or during study)\n* Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.\n\nParticipants did not meet criterion of having new gout flare if:\n\n• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.\n\nFlare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.","dispersionType":"95% Confidence Interval","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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 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 for any new flare for an additional year, for a total duration of 18 months.","id":"OG000","title":"Canakinumab 150 mg"},{"description":"Participants received 1 intramuscular 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.\n\nIn the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.\n\nIn the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.","id":"OG001","title":"Triamcinolone Acetonide 40 mg"}],"paramType":"MEAN","populationDescription":"The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From randomization to the end of the second extension period (72 weeks).","title":"Flare Rate Per Year","type":"SECONDARY","unitOfMeasure":"flares per patient per year"}