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NCT00560391 · BASELINE

Baseline characteristics

Dasatinib in Combination With Revlimid (and Dexamethasone) · Source last updated 2016-08-04

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
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      17
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG000
    title
    Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
  2. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG001
    title
    Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  3. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG002
    title
    Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  4. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG003
    title
    Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  5. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
    id
    BG004
    title
    Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.75
          value
          66.2
        2. group Id
          BG001
          spread
          4.73
          value
          69.3
        3. group Id
          BG002
          spread
          11.14
          value
          63.0
        4. group Id
          BG003
          spread
          5.92
          value
          69.7
        5. group Id
          BG004
          spread
          8.06
          value
          59.3
        6. group Id
          BG005
          spread
          9.19
          value
          63.4
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      21 - 45 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          20
      title
      46 - 65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          12
      title
      66 - 75 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          17
        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
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          34
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Asian
    param Type
    NUMBER
    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
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
      title
      Stage I
    2. 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
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          18
      title
      Not assessed
    description
    The ISS is an updated staging system for multiple myeloma. ISS divides multiple myeloma into three stages, which indicate the effect the disease is having on the body and how quickly or slowly it may develop. The ISS is based on the levels of blood proteins beta-2 microglobulin (β2M) and albumin. Stage I= β2M: \<3.5 mg/L, albumin: \>=3.5 g/dL; Stage II= β2M level: \< 3.5 mg/L and albumin: \< 3.5 g/dL, or β2M =3.5 to 5.5 mg/dL; Stage III: β2M level: \>=5.5 mg/L.
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          9
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IB
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
      title
      Stage IIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IIB
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
      title
      Stage IIIA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IIIB
    7. 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
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          8
      title
      Not Assessed
    description
    Myeloma is classified into 3 stages. Stage I: hemoglobin (Hb) \>10g/dL, normal calcium levels, normal skeletal survey or single plasmacytoma or osteoporosis, serum paraprotein level\<5g/dL if immunoglobulin G(IgG), \<3g/dL if IgA, urinary light chain excretion\<4g/24h. Stage II: fulfilling the criteria of neither I nor III. Stage III: Hb\<8.5g/dL, high calcium \>12mg/dL, Skeletal survey of 3 or more lytic bone lesions, serum paraprotein \>7g/dL if IgG,\>5g/dL if IgA, urinary light chain excretion \>12g/24h. Each stage further subdivided: A= serum creatinine \<2mg/dL and B= serum creatinine \>2mg/dL.
    param Type
    NUMBER
    title
    Durie-Salmon Staging System
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          18
          value
          4.9
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          5
          value
          4.0
        3. group Id
          BG002
          lower Limit
          7
          upper Limit
          11
          value
          7.5
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          6
          value
          5.2
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          16
          value
          3.7
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          18
          value
          4.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from diagnosis to first dosing
    unit Of Measure
    years
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      17
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG000
    title
    Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
  2. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG001
    title
    Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  3. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG002
    title
    Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  4. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    BG003
    title
    Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  5. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
    id
    BG004
    title
    Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.75
          value
          66.2
        2. group Id
          BG001
          spread
          4.73
          value
          69.3
        3. group Id
          BG002
          spread
          11.14
          value
          63.0
        4. group Id
          BG003
          spread
          5.92
          value
          69.7
        5. group Id
          BG004
          spread
          8.06
          value
          59.3
        6. group Id
          BG005
          spread
          9.19
          value
          63.4
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      21 - 45 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          20
      title
      46 - 65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          12
      title
      66 - 75 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          17
        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
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          34
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Asian
    param Type
    NUMBER
    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
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
      title
      Stage I
    2. 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
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          18
      title
      Not assessed
    description
    The ISS is an updated staging system for multiple myeloma. ISS divides multiple myeloma into three stages, which indicate the effect the disease is having on the body and how quickly or slowly it may develop. The ISS is based on the levels of blood proteins beta-2 microglobulin (β2M) and albumin. Stage I= β2M: \<3.5 mg/L, albumin: \>=3.5 g/dL; Stage II= β2M level: \< 3.5 mg/L and albumin: \< 3.5 g/dL, or β2M =3.5 to 5.5 mg/dL; Stage III: β2M level: \>=5.5 mg/L.
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          9
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IB
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
      title
      Stage IIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IIB
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
      title
      Stage IIIA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
      title
      Stage IIIB
    7. 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
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          8
      title
      Not Assessed
    description
    Myeloma is classified into 3 stages. Stage I: hemoglobin (Hb) \>10g/dL, normal calcium levels, normal skeletal survey or single plasmacytoma or osteoporosis, serum paraprotein level\<5g/dL if immunoglobulin G(IgG), \<3g/dL if IgA, urinary light chain excretion\<4g/24h. Stage II: fulfilling the criteria of neither I nor III. Stage III: Hb\<8.5g/dL, high calcium \>12mg/dL, Skeletal survey of 3 or more lytic bone lesions, serum paraprotein \>7g/dL if IgG,\>5g/dL if IgA, urinary light chain excretion \>12g/24h. Each stage further subdivided: A= serum creatinine \<2mg/dL and B= serum creatinine \>2mg/dL.
    param Type
    NUMBER
    title
    Durie-Salmon Staging System
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          18
          value
          4.9
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          5
          value
          4.0
        3. group Id
          BG002
          lower Limit
          7
          upper Limit
          11
          value
          7.5
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          6
          value
          5.2
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          16
          value
          3.7
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          18
          value
          4.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from diagnosis to first dosing
    unit Of Measure
    years

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