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NCT01207440 · BASELINE

Baseline characteristics

Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) · Source last updated 2021-02-02

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
      203
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      65
    4. group Id
      BG003
      value
      18
    5. group Id
      BG004
      value
      48
    6. group Id
      BG005
      value
      46
    7. group Id
      BG006
      value
      5
    8. group Id
      BG007
      value
      449
    units
    Participants
groups
  1. description
    CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG000
    title
    Cohort A: CP-CML R-I
  2. description
    CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG001
    title
    Cohort B: CP-CML With T315I Mutation
  3. description
    AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG002
    title
    Cohort C: AP-CML R-I
  4. description
    AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG003
    title
    Cohort D: AP-CML With T315I Mutation
  5. description
    BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG004
    title
    Cohort E: BP-CML/Ph+ ALL R-I
  6. description
    BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG005
    title
    Cohort F: BP-CML or Ph+ ALL With T315I Mutation
  7. description
    Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG006
    title
    Unassigned to Cohorts A-F
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          94
          value
          61.0
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          87
          value
          52.0
        3. group Id
          BG002
          lower Limit
          23
          upper Limit
          82
          value
          60.0
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          78
          value
          54.0
        5. group Id
          BG004
          lower Limit
          18
          upper Limit
          74
          value
          54.0
        6. group Id
          BG005
          lower Limit
          18
          upper Limit
          80
          value
          56.0
        7. group Id
          BG006
          lower Limit
          51
          upper Limit
          71
          value
          63.0
        8. group Id
          BG007
          lower Limit
          18
          upper Limit
          94
          value
          59.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          211
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          238
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          42
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          407
        title
        Not Hispanic or Latino
      3. 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
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        title
        American Indian/Alaska native
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          59
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          25
        title
        Black/African American
      4. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          352
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        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
          8
        title
        Unknown
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          267
        title
        ECOG=0
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          147
        title
        ECOG=1
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          34
        title
        ECOG=2
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          448
        units
        Participants
    description
    ECOG-PS measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    1 participant from the cohort F had missing ECOG data.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.45
          upper Limit
          27.43
          value
          7.85
        2. group Id
          BG001
          lower Limit
          1.16
          upper Limit
          19.49
          value
          4.78
        3. group Id
          BG002
          lower Limit
          0.33
          upper Limit
          28.47
          value
          7.13
        4. group Id
          BG003
          lower Limit
          1.17
          upper Limit
          15.90
          value
          6.61
        5. group Id
          BG004
          lower Limit
          0.62
          upper Limit
          27.21
          value
          3.96
        6. group Id
          BG005
          lower Limit
          0.46
          upper Limit
          14.14
          value
          1.63
        7. group Id
          BG006
          lower Limit
          1.74
          upper Limit
          18.60
          value
          4.80
        8. group Id
          BG007
          lower Limit
          0.33
          upper Limit
          28.47
          value
          6.09
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time From Diagnosis to First Dose
    unit Of Measure
    years
population Description
The safety population included all participants who received at least 1 dose of ponatinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      203
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      65
    4. group Id
      BG003
      value
      18
    5. group Id
      BG004
      value
      48
    6. group Id
      BG005
      value
      46
    7. group Id
      BG006
      value
      5
    8. group Id
      BG007
      value
      449
    units
    Participants
groups
  1. description
    CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG000
    title
    Cohort A: CP-CML R-I
  2. description
    CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG001
    title
    Cohort B: CP-CML With T315I Mutation
  3. description
    AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG002
    title
    Cohort C: AP-CML R-I
  4. description
    AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG003
    title
    Cohort D: AP-CML With T315I Mutation
  5. description
    BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG004
    title
    Cohort E: BP-CML/Ph+ ALL R-I
  6. description
    BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG005
    title
    Cohort F: BP-CML or Ph+ ALL With T315I Mutation
  7. description
    Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
    id
    BG006
    title
    Unassigned to Cohorts A-F
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          94
          value
          61.0
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          87
          value
          52.0
        3. group Id
          BG002
          lower Limit
          23
          upper Limit
          82
          value
          60.0
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          78
          value
          54.0
        5. group Id
          BG004
          lower Limit
          18
          upper Limit
          74
          value
          54.0
        6. group Id
          BG005
          lower Limit
          18
          upper Limit
          80
          value
          56.0
        7. group Id
          BG006
          lower Limit
          51
          upper Limit
          71
          value
          63.0
        8. group Id
          BG007
          lower Limit
          18
          upper Limit
          94
          value
          59.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          211
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          238
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          42
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          407
        title
        Not Hispanic or Latino
      3. 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
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        title
        American Indian/Alaska native
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          59
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          25
        title
        Black/African American
      4. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          352
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        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
          8
        title
        Unknown
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          267
        title
        ECOG=0
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          147
        title
        ECOG=1
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          34
        title
        ECOG=2
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          448
        units
        Participants
    description
    ECOG-PS measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    1 participant from the cohort F had missing ECOG data.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.45
          upper Limit
          27.43
          value
          7.85
        2. group Id
          BG001
          lower Limit
          1.16
          upper Limit
          19.49
          value
          4.78
        3. group Id
          BG002
          lower Limit
          0.33
          upper Limit
          28.47
          value
          7.13
        4. group Id
          BG003
          lower Limit
          1.17
          upper Limit
          15.90
          value
          6.61
        5. group Id
          BG004
          lower Limit
          0.62
          upper Limit
          27.21
          value
          3.96
        6. group Id
          BG005
          lower Limit
          0.46
          upper Limit
          14.14
          value
          1.63
        7. group Id
          BG006
          lower Limit
          1.74
          upper Limit
          18.60
          value
          4.80
        8. group Id
          BG007
          lower Limit
          0.33
          upper Limit
          28.47
          value
          6.09
      denoms
      1. counts
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          48
        6. group Id
          BG005
          value
          46
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          449
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time From Diagnosis to First Dose
    unit Of Measure
    years
population Description
The safety population included all participants who received at least 1 dose of ponatinib.

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Preserved source evidence · Not medical advice