{"denoms":[{"counts":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"35"},{"groupId":"BG004","value":"22"},{"groupId":"BG005","value":"24"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"18"},{"groupId":"BG009","value":"203"}],"units":"Participants"}],"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":"BG000","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":"BG001","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":"BG002","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":"BG003","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":"BG004","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":"BG005","title":"Epoch 2: TRAPS: Placebo"},{"description":"Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing\n\n≤ 40 kg) q4w","id":"BG006","title":"Epoch 2: Non-randomized Open Label Treatment - crFMF"},{"description":"Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing\n\n≤ 40 kg) q4w.","id":"BG007","title":"Epoch 2: Non-randomized Open Label HIDS/MKD"},{"description":"Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.","id":"BG008","title":"Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS"},{"description":"Total of all reporting groups","id":"BG009","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"2","spread":"15.02","upperLimit":"60","value":"18.0"},{"groupId":"BG001","lowerLimit":"4","spread":"13.38","upperLimit":"69","value":"18.0"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG002","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG003","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG004","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG005","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG006","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF cohort - randomized data only.","groupId":"BG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG009","lowerLimit":"2","spread":"14.10","upperLimit":"69","value":"18"}]}],"title":"crFMF cohort - randomized"},{"categories":[{"measurements":[{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG000","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG001","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG002","lowerLimit":"2","spread":"8.49","upperLimit":"43","value":"12.0"},{"groupId":"BG003","lowerLimit":"3","spread":"11.64","upperLimit":"47","value":"9.0"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG004","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG005","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG006","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect HIDS/MKD cohort - randomized data only.","groupId":"BG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG009","lowerLimit":"2","spread":"10.08","upperLimit":"47","value":"11.0"}]}],"title":"HIDS/MKD cohort - randomized"},{"categories":[{"measurements":[{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG000","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG001","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG002","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG003","lowerLimit":"NA","spread":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG004","lowerLimit":"3","spread":"19.22","upperLimit":"76","value":"13.5"},{"groupId":"BG005","lowerLimit":"2","spread":"18.25","upperLimit":"57","value":"16.5"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG006","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflect TRAPS cohort - randomized data only.","groupId":"BG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG009","lowerLimit":"2","spread":"18.55","upperLimit":"76","value":"15.5"}]}],"title":"TRAPS cohort - randomized"},{"categories":[{"measurements":[{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG006","lowerLimit":"20","upperLimit":"29","value":"24.5"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects crFMF non-randomized data only.","groupId":"BG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG009","lowerLimit":"20","upperLimit":"29","value":"24.5"}]}],"title":"crFMF - non-randomized"},{"categories":[{"measurements":[{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG006","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG007","lowerLimit":"1","upperLimit":"1","value":"1.0"},{"comment":"This row reflects HIDS/MIK non-randomized data only.","groupId":"BG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG009","lowerLimit":"1","upperLimit":"1","value":"1.0"}]}],"title":"HIDS/MKD - non-randomized"},{"categories":[{"measurements":[{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG006","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"This row reflects roll-over TRAPS non-randomized data only.","groupId":"BG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"BG008","lowerLimit":"15","upperLimit":"81","value":"42.5"},{"groupId":"BG009","lowerLimit":"15","upperLimit":"81","value":"42.5"}]}],"title":"roll-over TRAPS - non-randomized"}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"19"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"13"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"7"},{"groupId":"BG009","value":"104"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"12"},{"groupId":"BG005","value":"11"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"11"},{"groupId":"BG009","value":"99"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"11"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"18"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"16"},{"groupId":"BG009","value":"174"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"18"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}]}