{"classes":[{"categories":[{"measurements":[{"comment":"Not observed. Less than 50% participants with a flare.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"141.0","upperLimit":"449.0","value":"236.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.\n\n* Reappearance of fever (\\>38°C, lasting for at least 2 consecutive days) not due to infections\n* Flare according to the JIA pediatric criteria for flare (all criteria must have been met):\n* ≥ 30% worsening in at least 3 of the first 6 response variables\n* ≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II.","dispersionType":"95% Confidence Interval","groups":[{"description":"In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \\>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.","id":"OG000","title":"Canakinumab"},{"description":"Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \\>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set in Part II","reportingStatus":"POSTED","timeFrame":"Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)","title":"Part II: Survival Estimate of Time to Flare","type":"PRIMARY","unitOfMeasure":"Days"}