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NCT01102426 · BASELINE

Baseline characteristics

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma · Source last updated 2020-11-10

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
      171
    2. group Id
      BG001
      value
      84
    3. group Id
      BG002
      value
      255
    units
    Participants
groups
  1. description
    plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
    id
    BG000
    title
    Plitidepsin+Dexamethasone
  2. description
    dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
    id
    BG001
    title
    Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          124
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          131
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          85
          value
          64
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          85
          value
          65
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          85
          value
          65
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          123
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          132
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Czechia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      United Kingdom
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Portugal
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      New Zealand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      South Korea
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Netherlands
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          99
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          116
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          39
        title
        PS 2
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        PS 3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active, able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours PS 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours PS 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Non Secretory
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          56
        title
        Secretory IgA
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Secretory IgD
      4. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          152
        title
        Secretory IgG
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Secretory IgM
      6. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          37
        title
        Secretory Light chain disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    MM type at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Stage A
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          30
        title
        Stage IA
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Stage IB
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Stage II
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Stage IIA
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIB
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Stage III
      8. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          128
        title
        Stage IIIA
      9. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        Stage IIIB
      10. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Durie-Salmon stage at diagnosis
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    Stage I: small number of myeloma cells. All are present:Hemoglobin\>100 g/L;Blood calcium\<2.8 mmol/L;No areas of bone damage or a solitary plasmacytoma of the bone;IgG\<50 g/L;IgA\<30 g/L;Urine M-protein\<4 g Stage II: Moderate number of myeloma cells. The features are between stage 1 and 3 Stage III: Large number of myeloma cells. One/more are present: Hemoglobin\<85 g/L;Blood calcium\>2.8 mmol/L;Several areas of bone damage;IgG\>70 g/L;IgA\>50 g/L;Urine M-protein\>12 g Substage A: Kidney function is normal. Creatinine\<180 µmol/L. Substage B: Kidney function is abnormal. Creatinine\>=180 µmol/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage at diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          105
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          59
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          38
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          53
        title
        Not stage at diagnosis
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level. Stage I: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L. Stage II: Beta-2-microglobulin level less than 3.5 mg/L and Albumin level less than 35 g/L or beta-2-microglobulin level is more than 3.5 mg/L but less than 5.5 mg/L and any albumin level. Stage III: Beta-2-microglobulin is 5.5 mg/L or more and any albumin level.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          55
        title
        Standard risk
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          54
        title
        High risk
      3. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          146
        title
        NA/ND/UK
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    NA: not available; ND: not done; UK: unknown.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic risk group at diagnosis
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          103
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          152
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior radiotherapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          7
          upper Limit
          14.6
          value
          10.4
        2. group Id
          BG001
          lower Limit
          7.4
          upper Limit
          14.6
          value
          10.1
        3. group Id
          BG002
          lower Limit
          7
          upper Limit
          14.6
          value
          10.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hb
    unit Of Measure
    g/dL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      171
    2. group Id
      BG001
      value
      84
    3. group Id
      BG002
      value
      255
    units
    Participants
groups
  1. description
    plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
    id
    BG000
    title
    Plitidepsin+Dexamethasone
  2. description
    dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
    id
    BG001
    title
    Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          124
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          131
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          85
          value
          64
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          85
          value
          65
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          85
          value
          65
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          123
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          132
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Czechia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      United Kingdom
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Portugal
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      New Zealand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      South Korea
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
      title
      Netherlands
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          99
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          116
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          39
        title
        PS 2
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        PS 3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active, able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours PS 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours PS 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Non Secretory
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          56
        title
        Secretory IgA
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Secretory IgD
      4. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          152
        title
        Secretory IgG
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Secretory IgM
      6. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          37
        title
        Secretory Light chain disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    MM type at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Stage A
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          30
        title
        Stage IA
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Stage IB
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Stage II
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Stage IIA
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIB
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Stage III
      8. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          128
        title
        Stage IIIA
      9. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        Stage IIIB
      10. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Durie-Salmon stage at diagnosis
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    Stage I: small number of myeloma cells. All are present:Hemoglobin\>100 g/L;Blood calcium\<2.8 mmol/L;No areas of bone damage or a solitary plasmacytoma of the bone;IgG\<50 g/L;IgA\<30 g/L;Urine M-protein\<4 g Stage II: Moderate number of myeloma cells. The features are between stage 1 and 3 Stage III: Large number of myeloma cells. One/more are present: Hemoglobin\<85 g/L;Blood calcium\>2.8 mmol/L;Several areas of bone damage;IgG\>70 g/L;IgA\>50 g/L;Urine M-protein\>12 g Substage A: Kidney function is normal. Creatinine\<180 µmol/L. Substage B: Kidney function is abnormal. Creatinine\>=180 µmol/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage at diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          105
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          59
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          38
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          53
        title
        Not stage at diagnosis
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level. Stage I: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L. Stage II: Beta-2-microglobulin level less than 3.5 mg/L and Albumin level less than 35 g/L or beta-2-microglobulin level is more than 3.5 mg/L but less than 5.5 mg/L and any albumin level. Stage III: Beta-2-microglobulin is 5.5 mg/L or more and any albumin level.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          55
        title
        Standard risk
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          54
        title
        High risk
      3. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          146
        title
        NA/ND/UK
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    description
    NA: not available; ND: not done; UK: unknown.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic risk group at diagnosis
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          103
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          152
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior radiotherapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          7
          upper Limit
          14.6
          value
          10.4
        2. group Id
          BG001
          lower Limit
          7.4
          upper Limit
          14.6
          value
          10.1
        3. group Id
          BG002
          lower Limit
          7
          upper Limit
          14.6
          value
          10.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hb
    unit Of Measure
    g/dL

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Preserved source evidence · Not medical advice