{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Fisher's exact test"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0020","statisticalMethod":"Fisher's exact test"},{"groupIds":["OG004","OG005"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0050","statisticalMethod":"Fisher's exact test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.29"},{"groupId":"OG001","value":"6.25"},{"groupId":"OG002","value":"35.14"},{"groupId":"OG003","value":"5.71"},{"groupId":"OG004","value":"45.45"},{"groupId":"OG005","value":"8.33"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"35"},{"groupId":"OG004","value":"22"},{"groupId":"OG005","value":"24"}],"units":"Participants"}],"description":"Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) \\<2 and C-reactive protein (CRP) within normal range (\\<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.","groups":[{"description":"During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \\<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.","id":"OG000","title":"Epoch 2: crFMF: 150 mg"},{"description":"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.\n\n150mg, participants were uptitrated to open-label canakinumab 300 mg","id":"OG001","title":"Epoch 2: crCMF: Placebo"},{"description":"During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \\<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.","id":"OG002","title":"Epoch 2: HIDS/MKD: 150 mg"},{"description":"During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.","id":"OG003","title":"Epoch 2: HIDS/MKD: Placebo"},{"description":"During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \\<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration","id":"OG004","title":"Epoch 2: TRAPS: 150 mg"},{"description":"During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \\<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.","id":"OG005","title":"Epoch 2: TRAPS: Placebo"}],"paramType":"NUMBER","populationDescription":"The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.","reportingStatus":"POSTED","timeFrame":"16 weeks","title":"Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}