Skip to content
← Full study record

NCT02059291 · BASELINE

Baseline characteristics

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers · Source last updated 2018-05-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      37
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      2
    8. group Id
      BG007
      value
      2
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      203
    units
    Participants
groups
  1. 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
  2. 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. 150mg, participants were uptitrated to open-label canakinumab 300 mg
    id
    BG001
    title
    Epoch 2: crCMF: Placebo
  3. 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
  4. 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
  5. 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
  6. 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
  7. description
    Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w
    id
    BG006
    title
    Epoch 2: Non-randomized Open Label Treatment - crFMF
  8. 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 ≤ 40 kg) q4w.
    id
    BG007
    title
    Epoch 2: Non-randomized Open Label HIDS/MKD
  9. 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
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          spread
          15.02
          upper Limit
          60
          value
          18.0
        2. group Id
          BG001
          lower Limit
          4
          spread
          13.38
          upper Limit
          69
          value
          18.0
        3. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG002
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG003
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG004
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG005
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          14.10
          upper Limit
          69
          value
          18
      title
      crFMF cohort - randomized
    2. categories
      1. measurements
        1. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG000
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG001
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        3. group Id
          BG002
          lower Limit
          2
          spread
          8.49
          upper Limit
          43
          value
          12.0
        4. group Id
          BG003
          lower Limit
          3
          spread
          11.64
          upper Limit
          47
          value
          9.0
        5. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG004
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG005
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          10.08
          upper Limit
          47
          value
          11.0
      title
      HIDS/MKD cohort - randomized
    3. categories
      1. measurements
        1. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG000
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG001
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG002
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG003
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        5. group Id
          BG004
          lower Limit
          3
          spread
          19.22
          upper Limit
          76
          value
          13.5
        6. group Id
          BG005
          lower Limit
          2
          spread
          18.25
          upper Limit
          57
          value
          16.5
        7. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          18.55
          upper Limit
          76
          value
          15.5
      title
      TRAPS cohort - randomized
    4. categories
      1. measurements
        1. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. group Id
          BG006
          lower Limit
          20
          upper Limit
          29
          value
          24.5
        8. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          20
          upper Limit
          29
          value
          24.5
      title
      crFMF - non-randomized
    5. categories
      1. measurements
        1. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          1
          value
          1.0
        9. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          1
          upper Limit
          1
          value
          1.0
      title
      HIDS/MKD - non-randomized
    6. categories
      1. measurements
        1. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. group Id
          BG008
          lower Limit
          15
          upper Limit
          81
          value
          42.5
        10. group Id
          BG009
          lower Limit
          15
          upper Limit
          81
          value
          42.5
      title
      roll-over TRAPS - non-randomized
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          99
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          174
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      37
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      2
    8. group Id
      BG007
      value
      2
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      203
    units
    Participants
groups
  1. 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
  2. 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. 150mg, participants were uptitrated to open-label canakinumab 300 mg
    id
    BG001
    title
    Epoch 2: crCMF: Placebo
  3. 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
  4. 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
  5. 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
  6. 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
  7. description
    Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w
    id
    BG006
    title
    Epoch 2: Non-randomized Open Label Treatment - crFMF
  8. 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 ≤ 40 kg) q4w.
    id
    BG007
    title
    Epoch 2: Non-randomized Open Label HIDS/MKD
  9. 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
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          spread
          15.02
          upper Limit
          60
          value
          18.0
        2. group Id
          BG001
          lower Limit
          4
          spread
          13.38
          upper Limit
          69
          value
          18.0
        3. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG002
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG003
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG004
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG005
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflects crFMF cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          14.10
          upper Limit
          69
          value
          18
      title
      crFMF cohort - randomized
    2. categories
      1. measurements
        1. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG000
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG001
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        3. group Id
          BG002
          lower Limit
          2
          spread
          8.49
          upper Limit
          43
          value
          12.0
        4. group Id
          BG003
          lower Limit
          3
          spread
          11.64
          upper Limit
          47
          value
          9.0
        5. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG004
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG005
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflect HIDS/MKD cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          10.08
          upper Limit
          47
          value
          11.0
      title
      HIDS/MKD cohort - randomized
    3. categories
      1. measurements
        1. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG000
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG001
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG002
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG003
          lower Limit
          NA
          spread
          NA
          upper Limit
          NA
          value
          NA
        5. group Id
          BG004
          lower Limit
          3
          spread
          19.22
          upper Limit
          76
          value
          13.5
        6. group Id
          BG005
          lower Limit
          2
          spread
          18.25
          upper Limit
          57
          value
          16.5
        7. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflect TRAPS cohort - randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          2
          spread
          18.55
          upper Limit
          76
          value
          15.5
      title
      TRAPS cohort - randomized
    4. categories
      1. measurements
        1. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. group Id
          BG006
          lower Limit
          20
          upper Limit
          29
          value
          24.5
        8. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. comment
          This row reflects crFMF non-randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          20
          upper Limit
          29
          value
          24.5
      title
      crFMF - non-randomized
    5. categories
      1. measurements
        1. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          1
          value
          1.0
        9. comment
          This row reflects HIDS/MIK non-randomized data only.
          group Id
          BG008
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        10. group Id
          BG009
          lower Limit
          1
          upper Limit
          1
          value
          1.0
      title
      HIDS/MKD - non-randomized
    6. categories
      1. measurements
        1. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG000
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        2. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG001
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        3. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG002
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        4. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG003
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        5. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG004
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        6. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG005
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        7. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG006
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        8. comment
          This row reflects roll-over TRAPS non-randomized data only.
          group Id
          BG007
          lower Limit
          NA
          upper Limit
          NA
          value
          NA
        9. group Id
          BG008
          lower Limit
          15
          upper Limit
          81
          value
          42.5
        10. group Id
          BG009
          lower Limit
          15
          upper Limit
          81
          value
          42.5
      title
      roll-over TRAPS - non-randomized
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          99
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          174
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice