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NCT01677286 · BASELINE

Baseline characteristics

Safety and Effect of Doxycycline in Patients With Amyloidosis · Source last updated 2017-08-01

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
      25
    units
    Participants
groups
  1. description
    Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
    id
    BG000
    title
    Doxycycline 100 mg po Bid x 12 Months
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          82
          value
          65
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Multiple
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Not hispanic or latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Unknown/not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          294
          value
          385
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        units
        Participants
    description
    Study participants with predominant cardiac amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
    title
    Brain Natriuretic Peptide (BNP)
    unit Of Measure
    pg/mL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.07
          value
          0.11
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        units
        Participants
    description
    Study participants with predominant cardiac amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
    title
    Troponin I
    unit Of Measure
    ng/mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          36.5
          value
          83.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    description
    Study participants with predominant renal amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
    title
    Creatinine Clearance (mL/min)
    unit Of Measure
    mL/min
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.15
          value
          5.99
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    description
    Study participants with predominant renal amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
    title
    Proteinuria (g/day)
    unit Of Measure
    g/day
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    units
    Participants
groups
  1. description
    Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
    id
    BG000
    title
    Doxycycline 100 mg po Bid x 12 Months
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          82
          value
          65
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Multiple
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Not hispanic or latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      Unknown/not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          294
          value
          385
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        units
        Participants
    description
    Study participants with predominant cardiac amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
    title
    Brain Natriuretic Peptide (BNP)
    unit Of Measure
    pg/mL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.07
          value
          0.11
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        units
        Participants
    description
    Study participants with predominant cardiac amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
    title
    Troponin I
    unit Of Measure
    ng/mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          36.5
          value
          83.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    description
    Study participants with predominant renal amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
    title
    Creatinine Clearance (mL/min)
    unit Of Measure
    mL/min
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.15
          value
          5.99
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    description
    Study participants with predominant renal amyloid involvement.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
    title
    Proteinuria (g/day)
    unit Of Measure
    g/day

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Preserved source evidence · Not medical advice