{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"113.44","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0513","paramType":"Odds Ratio (OR)","paramValue":"8.17","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"366.24","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2168","paramType":"Odds Ratio (OR)","paramValue":"6.00","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"313.49","groupIds":["OG004","OG005"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3571","paramType":"Odds Ratio (OR)","paramValue":"4.50","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"77.8"},{"groupId":"OG001","value":"30.0"},{"groupId":"OG002","value":"50.0"},{"groupId":"OG003","value":"14.3"},{"groupId":"OG004","value":"75.0"},{"groupId":"OG005","value":"40.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"5"}],"units":"Participants"}],"description":"A responder was defined as a participant who had no flare between week 16 and week 40.","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 re-randomized set was analyzed.","reportingStatus":"POSTED","timeFrame":"40 weeks","title":"Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}