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NCT01546038 · BASELINE

Baseline characteristics

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

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
      23
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      71
    5. group Id
      BG004
      value
      88
    6. group Id
      BG005
      value
      44
    7. group Id
      BG006
      value
      255
    units
    Participants
groups
  1. description
    Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
    id
    BG000
    title
    Phase 1B: Glasdegib + LDAC
  2. description
    Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
    id
    BG001
    title
    Phase 1B: Glasdegib + Decitabine
  3. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    BG002
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
  4. description
    Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
    id
    BG003
    title
    Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
  5. description
    Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
    id
    BG004
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC
  6. description
    Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
    id
    BG005
    title
    Phase 2 Unfit: LDAC Alone
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          75.8
        2. group Id
          BG001
          spread
          4.4
          value
          75.0
        3. group Id
          BG002
          spread
          12.7
          value
          54.9
        4. group Id
          BG003
          spread
          9.6
          value
          61.9
        5. group Id
          BG004
          spread
          6.2
          value
          76.2
        6. group Id
          BG005
          spread
          4.9
          value
          74.5
        7. group Id
          BG006
          spread
          13.9
          value
          66.8
    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
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          69
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          170
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      23
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      71
    5. group Id
      BG004
      value
      88
    6. group Id
      BG005
      value
      44
    7. group Id
      BG006
      value
      255
    units
    Participants
groups
  1. description
    Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
    id
    BG000
    title
    Phase 1B: Glasdegib + LDAC
  2. description
    Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
    id
    BG001
    title
    Phase 1B: Glasdegib + Decitabine
  3. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    BG002
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
  4. description
    Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
    id
    BG003
    title
    Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
  5. description
    Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
    id
    BG004
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC
  6. description
    Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
    id
    BG005
    title
    Phase 2 Unfit: LDAC Alone
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          75.8
        2. group Id
          BG001
          spread
          4.4
          value
          75.0
        3. group Id
          BG002
          spread
          12.7
          value
          54.9
        4. group Id
          BG003
          spread
          9.6
          value
          61.9
        5. group Id
          BG004
          spread
          6.2
          value
          76.2
        6. group Id
          BG005
          spread
          4.9
          value
          74.5
        7. group Id
          BG006
          spread
          13.9
          value
          66.8
    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
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          69
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          170
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice