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NCT00261846 · BASELINE

Baseline characteristics

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias · Source last updated 2017-07-27

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
      195
    2. group Id
      BG001
      value
      89
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      38
    5. group Id
      BG004
      value
      50
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      79
    8. group Id
      BG007
      value
      64
    9. group Id
      BG008
      value
      24
    10. group Id
      BG009
      value
      570
    units
    Participants
groups
  1. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    BG000
    title
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
  2. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    BG001
    title
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
  3. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
    id
    BG002
    title
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
  4. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
    id
    BG003
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
  5. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
    id
    BG004
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
  6. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
    id
    BG005
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
    id
    BG006
    title
    AP-CML Total (Part 2)
  8. description
    All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
    id
    BG007
    title
    BP-CML Total (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    BG008
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
  10. description
    Total of all reporting groups
    id
    BG009
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
      title
      <18 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          29
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          179
      title
      Between 18 and 44 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          45
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          272
      title
      Between 45 and 64 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          119
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          270
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          44
        8. group Id
          BG007
          value
          42
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          300
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
All-treated population - included all enrolled participants who received at least one dose of bosutinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      195
    2. group Id
      BG001
      value
      89
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      38
    5. group Id
      BG004
      value
      50
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      79
    8. group Id
      BG007
      value
      64
    9. group Id
      BG008
      value
      24
    10. group Id
      BG009
      value
      570
    units
    Participants
groups
  1. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    BG000
    title
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
  2. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    BG001
    title
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
  3. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
    id
    BG002
    title
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
  4. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
    id
    BG003
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
  5. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
    id
    BG004
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
  6. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
    id
    BG005
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
    id
    BG006
    title
    AP-CML Total (Part 2)
  8. description
    All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
    id
    BG007
    title
    BP-CML Total (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    BG008
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
  10. description
    Total of all reporting groups
    id
    BG009
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
      title
      <18 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          29
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          179
      title
      Between 18 and 44 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          45
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          272
      title
      Between 45 and 64 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          119
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          270
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          44
        8. group Id
          BG007
          value
          42
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          300
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
All-treated population - included all enrolled participants who received at least one dose of bosutinib.

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

Preserved source evidence · Not medical advice