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NCT02100657 · BASELINE

Baseline characteristics

Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2020-10-12

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
      8
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      27
    4. group Id
      BG003
      value
      39
    units
    Participants
groups
  1. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG000
    title
    Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)
  2. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG001
    title
    Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  3. description
    Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG002
    title
    Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          18
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          21
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          57
          upper Limit
          80
          value
          68
        2. group Id
          BG001
          lower Limit
          58
          upper Limit
          76
          value
          67
        3. group Id
          BG002
          lower Limit
          51
          upper Limit
          80
          value
          64
        4. group Id
          BG003
          lower Limit
          51
          upper Limit
          80
          value
          66
    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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          21
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          36
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          8
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          29
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        PS 2
    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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Non-secretory
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Oligosecretory
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          36
        title
        Secretory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple myeloma type at diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          24
        title
        Stage III
    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 * Immunoglobulin G (IgG) \<50 g/L * Immunoglobulin A (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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          24
        title
        Stage III
    description
    Stage I: small number of myeloma cells. All are present: * Hemoglobin more than 100 g/L * Blood calcium less than 2.8 mmol/L * No areas of bone damage or a solitary plasmacytoma of the bone * IgG less than 50 g/L * IgA less than 30 g/L * Urine M-protein less than 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 less than 85 g/L * Blood calcium more than 2.8 mmol/L * Several areas of bone damage * IgG more than 70 g/L * IgA more than 50 g/L * Urine M-protein more than 12 g
    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
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          30
        title
        Substage A
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        title
        Substage B
    description
    The stages of multiple myeloma are further divided according to creatinine level in the blood, which shows how well the kidneys are working. Substage A: Kidney function is normal. Creatinine level is less than 180 µmol/L. Substage B: Kidney function is abnormal. Creatinine level is 180 µmol/L or more.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon subclassification at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          14
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          10
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        title
        Unknown
    description
    The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level. Stage 1: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L. Stage 2: 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 3: 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
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          15
        title
        Relapsed
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          24
        title
        Total refractory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status with respect to last prior therapy
    unit Of Measure
    Participants
  12. classes
    1. 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
        CR
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        VGPR
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        title
        PR
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        SD
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        title
        PD
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        title
        UK
    description
    CR, complete response; PD, progressive disease; PR, partial response; RD, recommended dose; SD, stable disease; UK, unknown; VGPR, very good partial response.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best response to last prior anticancer therapy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      27
    4. group Id
      BG003
      value
      39
    units
    Participants
groups
  1. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG000
    title
    Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)
  2. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG001
    title
    Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  3. description
    Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    BG002
    title
    Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          18
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          21
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          57
          upper Limit
          80
          value
          68
        2. group Id
          BG001
          lower Limit
          58
          upper Limit
          76
          value
          67
        3. group Id
          BG002
          lower Limit
          51
          upper Limit
          80
          value
          64
        4. group Id
          BG003
          lower Limit
          51
          upper Limit
          80
          value
          66
    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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          21
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          36
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          8
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          29
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        PS 2
    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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Non-secretory
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Oligosecretory
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          36
        title
        Secretory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple myeloma type at diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          24
        title
        Stage III
    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 * Immunoglobulin G (IgG) \<50 g/L * Immunoglobulin A (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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          24
        title
        Stage III
    description
    Stage I: small number of myeloma cells. All are present: * Hemoglobin more than 100 g/L * Blood calcium less than 2.8 mmol/L * No areas of bone damage or a solitary plasmacytoma of the bone * IgG less than 50 g/L * IgA less than 30 g/L * Urine M-protein less than 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 less than 85 g/L * Blood calcium more than 2.8 mmol/L * Several areas of bone damage * IgG more than 70 g/L * IgA more than 50 g/L * Urine M-protein more than 12 g
    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
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          30
        title
        Substage A
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        title
        Substage B
    description
    The stages of multiple myeloma are further divided according to creatinine level in the blood, which shows how well the kidneys are working. Substage A: Kidney function is normal. Creatinine level is less than 180 µmol/L. Substage B: Kidney function is abnormal. Creatinine level is 180 µmol/L or more.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon subclassification at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          14
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          10
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        title
        Unknown
    description
    The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level. Stage 1: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L. Stage 2: 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 3: 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
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          15
        title
        Relapsed
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          24
        title
        Total refractory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status with respect to last prior therapy
    unit Of Measure
    Participants
  12. classes
    1. 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
        CR
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        VGPR
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          12
        title
        PR
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        SD
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        title
        PD
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        title
        UK
    description
    CR, complete response; PD, progressive disease; PR, partial response; RD, recommended dose; SD, stable disease; UK, unknown; VGPR, very good partial response.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best response to last prior anticancer therapy
    unit Of Measure
    Participants

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