Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03201965 · BASELINE

Baseline characteristics

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis · Source last updated 2025-11-26

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
      28
    2. group Id
      BG001
      value
      193
    3. group Id
      BG002
      value
      195
    4. group Id
      BG003
      value
      416
    units
    Participants
groups
  1. description
    Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG000
    title
    Run-In: Daratumumab Plus CyBorD
  2. description
    Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG001
    title
    CyBorD
  3. description
    Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG002
    title
    Daratumumab Plus CyBorD
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          64.8
        2. group Id
          BG001
          spread
          9.66
          value
          64
        3. group Id
          BG002
          spread
          10.16
          value
          62.2
        4. group Id
          BG003
          spread
          10.03
          value
          63.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          174
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          241
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Undifferentiated Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          381
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          64
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          151
        4. group Id
          BG003
          value
          319
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          27
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      DENMARK
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          38
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          19
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          27
      title
      GREECE
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
      title
      HUNGARY
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          11
      title
      ISRAEL
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      ITALY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          141
      title
      <=65 kg
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          182
      title
      >65 to 85 kg
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          93
      title
      >85 kg
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Weight group in Kilograms (Kg)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          140
        4. group Id
          BG003
          value
          294
      title
      Baseline Organ Involvement: Heart
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          248
      title
      Baseline Organ Involvement: Kidney
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          35
      title
      Baseline Organ Involvement: Liver
    description
    Organ involvement assessment: biopsy. Heart: echo: mean wall thickness greater than (\>) 12 millimeter, no other cardiac cause; kidney: 24- hour urine protein \>0.5 gram per day, predominantly albumin; liver: total liver span \>15 centimeter in absence of heart failure or alkaline phosphatase \>1.5 times institutional upper limit of normal.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Major Organ Involvement
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.881
          value
          2.0
        2. group Id
          BG001
          spread
          1.03
          value
          2.0
        3. group Id
          BG002
          spread
          0.97
          value
          2.0
        4. group Id
          BG003
          spread
          0.99
          value
          2.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Number of Organs Involved
    unit Of Measure
    organs
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          143
      title
      1 Organ
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          166
      title
      2 Organs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          107
      title
      >=3 Organ
    description
    Number of participants whose 1 organ, 2 organs, 3 or more than 3 organs involved at baseline was reported. Organs like heart, kidney, and liver were considered.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Organs Involved
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          96
      title
      Class I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          172
      title
      Class II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          139
      title
      Class IIIa
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      Class IIIb
    description
    Cardiac stage is derived based on the combination of NT-proBNP (N-terminal pro b-type natriuretic peptide) and hs-cTnT (high sensitivity cardiac troponin T). Risk factor includes NT-proBNP \>332 nanogram per liter (ng/L) and Hs-cTnT \>54 ng/L. Stage I includes no markers above the cutoff, stage 2 includes one marker above the cutoff, stage 3a includes both markers above the cutoff, and stage 3b includes NT-proBNP \>8500 ng/L and hs-cTnT \>54 ng/L.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cardiac Stage Based on Mayo Clinic Cardiac Staging System
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          101
        4. group Id
          BG003
          value
          212
      title
      Class I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          176
      title
      Class II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          28
      title
      Class IIIA
    description
    The NYHA classification: Class I- No symptoms and no limitation in ordinary physical activity, example, shortness of breath when walking, climbing stairs; class II- mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; class IIIA- marked limitation in activity due to symptoms, even during less than ordinary activity, example, walking short distances (20-100 meter).Comfortable only at rest.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    New York Heart Association (NYHA) Class
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      28
    2. group Id
      BG001
      value
      193
    3. group Id
      BG002
      value
      195
    4. group Id
      BG003
      value
      416
    units
    Participants
groups
  1. description
    Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG000
    title
    Run-In: Daratumumab Plus CyBorD
  2. description
    Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG001
    title
    CyBorD
  3. description
    Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    BG002
    title
    Daratumumab Plus CyBorD
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          64.8
        2. group Id
          BG001
          spread
          9.66
          value
          64
        3. group Id
          BG002
          spread
          10.16
          value
          62.2
        4. group Id
          BG003
          spread
          10.03
          value
          63.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          174
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          241
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Undifferentiated Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          381
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          64
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          151
        4. group Id
          BG003
          value
          319
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          27
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      DENMARK
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          38
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          19
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          27
      title
      GREECE
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
      title
      HUNGARY
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          11
      title
      ISRAEL
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      ITALY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          141
      title
      <=65 kg
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          182
      title
      >65 to 85 kg
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          93
      title
      >85 kg
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Weight group in Kilograms (Kg)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          140
        4. group Id
          BG003
          value
          294
      title
      Baseline Organ Involvement: Heart
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          248
      title
      Baseline Organ Involvement: Kidney
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          35
      title
      Baseline Organ Involvement: Liver
    description
    Organ involvement assessment: biopsy. Heart: echo: mean wall thickness greater than (\>) 12 millimeter, no other cardiac cause; kidney: 24- hour urine protein \>0.5 gram per day, predominantly albumin; liver: total liver span \>15 centimeter in absence of heart failure or alkaline phosphatase \>1.5 times institutional upper limit of normal.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Major Organ Involvement
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.881
          value
          2.0
        2. group Id
          BG001
          spread
          1.03
          value
          2.0
        3. group Id
          BG002
          spread
          0.97
          value
          2.0
        4. group Id
          BG003
          spread
          0.99
          value
          2.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Number of Organs Involved
    unit Of Measure
    organs
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          143
      title
      1 Organ
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          166
      title
      2 Organs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          107
      title
      >=3 Organ
    description
    Number of participants whose 1 organ, 2 organs, 3 or more than 3 organs involved at baseline was reported. Organs like heart, kidney, and liver were considered.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Organs Involved
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          96
      title
      Class I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          172
      title
      Class II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          139
      title
      Class IIIa
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      Class IIIb
    description
    Cardiac stage is derived based on the combination of NT-proBNP (N-terminal pro b-type natriuretic peptide) and hs-cTnT (high sensitivity cardiac troponin T). Risk factor includes NT-proBNP \>332 nanogram per liter (ng/L) and Hs-cTnT \>54 ng/L. Stage I includes no markers above the cutoff, stage 2 includes one marker above the cutoff, stage 3a includes both markers above the cutoff, and stage 3b includes NT-proBNP \>8500 ng/L and hs-cTnT \>54 ng/L.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cardiac Stage Based on Mayo Clinic Cardiac Staging System
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          101
        4. group Id
          BG003
          value
          212
      title
      Class I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          176
      title
      Class II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          28
      title
      Class IIIA
    description
    The NYHA classification: Class I- No symptoms and no limitation in ordinary physical activity, example, shortness of breath when walking, climbing stairs; class II- mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; class IIIA- marked limitation in activity due to symptoms, even during less than ordinary activity, example, walking short distances (20-100 meter).Comfortable only at rest.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    New York Heart Association (NYHA) Class
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice