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NCT00261846 · OUTCOME

Cumulative Incidence of Progression/Death - Part 2

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Years 1, 2, 3, 4, and 5 (CP2L only)

What was measured

The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray's method. NA = not estimable. One year = 12 months.

Analysis population: All-treated population included all enrolled participants who received at least one dose of study medication.

Groups in this outcome

Bosutinib 500 mg, CP2L-CML IM-R (Part 2)

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.

Bosutinib 500 mg, CP2L-CML IM-I (Part 2)

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.

Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)

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.

Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.

Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.

Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.

Bosutinib 500 mg, AP-CML IM R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.

Bosutinib 500 mg, BP-CML IM R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.

Bosutinib 500 mg, Ph+ ALL (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)195
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)89
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)5
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)38
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)50
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)26
Bosutinib 500 mg, AP-CML IM R/I (Part 2)49
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)30
Bosutinib 500 mg, BP-CML IM R/I (Part 2)36
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)28
Bosutinib 500 mg, Ph+ ALL (Part 2)24

Reported measurements

Year 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)10.8Not reported7.216.1Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)4.5Not reported1.711.7Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)20.0Not reported3.5100.0Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)23.7Not reported13.441.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)12.0Not reported5.725.4Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)23.1Not reported11.446.6Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)28.6Not reported18.444.5Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)20.0Not reported9.840.9Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)47.2Not reported33.466.7Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)71.4Not reported56.590.3Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)58.3Not reported41.681.8Not reported
Year 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)19.0Not reported14.225.4Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)6.7Not reported3.114.6Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)40.0Not reported13.7100.0Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)23.7Not reported13.441.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)14.0Not reported7.027.8Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)30.8Not reported17.354.8Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)42.9Not reported31.059.2Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)23.3Not reported12.244.6Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)50.0Not reported36.169.3Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)71.4Not reported56.590.3Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)58.3Not reported41.681.8Not reported
Year 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)22.1Not reported16.928.7Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)9.0Not reported4.617.4Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)40.0Not reported13.7100.0Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)23.7Not reported13.441.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)16.0Not reported8.530.2Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)34.6Not reported20.458.7Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)44.9Not reported32.961.2Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)26.7Not reported14.748.3Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)50.0Not reported36.169.3Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)75.0Not reported60.692.9Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)58.3Not reported41.681.8Not reported
Year 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)22.6Not reported17.429.3Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)9.0Not reported4.617.4Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)40.0Not reported13.7100.0Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)23.7Not reported13.441.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)16.0Not reported8.530.2Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)34.6Not reported20.458.7Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)44.9Not reported32.961.2Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)26.7Not reported14.748.3Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)50.0Not reported36.169.3Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)75.0Not reported60.692.9Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)58.3Not reported41.681.8Not reported
Year 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)23.1Not reported17.929.8Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)10.1Not reported5.418.8Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, AP-CML IM R/I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, BP-CML IM R/I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Bosutinib 500 mg, Ph+ ALL (Part 2)NANot reportedNANAIn Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.2
        upper Limit
        16.1
        value
        10.8
      2. group Id
        OG001
        lower Limit
        1.7
        upper Limit
        11.7
        value
        4.5
      3. group Id
        OG002
        lower Limit
        3.5
        upper Limit
        100.0
        value
        20.0
      4. group Id
        OG003
        lower Limit
        13.4
        upper Limit
        41.9
        value
        23.7
      5. group Id
        OG004
        lower Limit
        5.7
        upper Limit
        25.4
        value
        12.0
      6. group Id
        OG005
        lower Limit
        11.4
        upper Limit
        46.6
        value
        23.1
      7. group Id
        OG006
        lower Limit
        18.4
        upper Limit
        44.5
        value
        28.6
      8. group Id
        OG007
        lower Limit
        9.8
        upper Limit
        40.9
        value
        20.0
      9. group Id
        OG008
        lower Limit
        33.4
        upper Limit
        66.7
        value
        47.2
      10. group Id
        OG009
        lower Limit
        56.5
        upper Limit
        90.3
        value
        71.4
      11. group Id
        OG010
        lower Limit
        41.6
        upper Limit
        81.8
        value
        58.3
    title
    Year 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.2
        upper Limit
        25.4
        value
        19.0
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        14.6
        value
        6.7
      3. group Id
        OG002
        lower Limit
        13.7
        upper Limit
        100.0
        value
        40.0
      4. group Id
        OG003
        lower Limit
        13.4
        upper Limit
        41.9
        value
        23.7
      5. group Id
        OG004
        lower Limit
        7.0
        upper Limit
        27.8
        value
        14.0
      6. group Id
        OG005
        lower Limit
        17.3
        upper Limit
        54.8
        value
        30.8
      7. group Id
        OG006
        lower Limit
        31.0
        upper Limit
        59.2
        value
        42.9
      8. group Id
        OG007
        lower Limit
        12.2
        upper Limit
        44.6
        value
        23.3
      9. group Id
        OG008
        lower Limit
        36.1
        upper Limit
        69.3
        value
        50.0
      10. group Id
        OG009
        lower Limit
        56.5
        upper Limit
        90.3
        value
        71.4
      11. group Id
        OG010
        lower Limit
        41.6
        upper Limit
        81.8
        value
        58.3
    title
    Year 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.9
        upper Limit
        28.7
        value
        22.1
      2. group Id
        OG001
        lower Limit
        4.6
        upper Limit
        17.4
        value
        9.0
      3. group Id
        OG002
        lower Limit
        13.7
        upper Limit
        100.0
        value
        40.0
      4. group Id
        OG003
        lower Limit
        13.4
        upper Limit
        41.9
        value
        23.7
      5. group Id
        OG004
        lower Limit
        8.5
        upper Limit
        30.2
        value
        16.0
      6. group Id
        OG005
        lower Limit
        20.4
        upper Limit
        58.7
        value
        34.6
      7. group Id
        OG006
        lower Limit
        32.9
        upper Limit
        61.2
        value
        44.9
      8. group Id
        OG007
        lower Limit
        14.7
        upper Limit
        48.3
        value
        26.7
      9. group Id
        OG008
        lower Limit
        36.1
        upper Limit
        69.3
        value
        50.0
      10. group Id
        OG009
        lower Limit
        60.6
        upper Limit
        92.9
        value
        75.0
      11. group Id
        OG010
        lower Limit
        41.6
        upper Limit
        81.8
        value
        58.3
    title
    Year 3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.4
        upper Limit
        29.3
        value
        22.6
      2. group Id
        OG001
        lower Limit
        4.6
        upper Limit
        17.4
        value
        9.0
      3. group Id
        OG002
        lower Limit
        13.7
        upper Limit
        100.0
        value
        40.0
      4. group Id
        OG003
        lower Limit
        13.4
        upper Limit
        41.9
        value
        23.7
      5. group Id
        OG004
        lower Limit
        8.5
        upper Limit
        30.2
        value
        16.0
      6. group Id
        OG005
        lower Limit
        20.4
        upper Limit
        58.7
        value
        34.6
      7. group Id
        OG006
        lower Limit
        32.9
        upper Limit
        61.2
        value
        44.9
      8. group Id
        OG007
        lower Limit
        14.7
        upper Limit
        48.3
        value
        26.7
      9. group Id
        OG008
        lower Limit
        36.1
        upper Limit
        69.3
        value
        50.0
      10. group Id
        OG009
        lower Limit
        60.6
        upper Limit
        92.9
        value
        75.0
      11. group Id
        OG010
        lower Limit
        41.6
        upper Limit
        81.8
        value
        58.3
    title
    Year 4
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.9
        upper Limit
        29.8
        value
        23.1
      2. group Id
        OG001
        lower Limit
        5.4
        upper Limit
        18.8
        value
        10.1
      3. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      8. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      9. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG008
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      10. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG009
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      11. comment
        In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
        group Id
        OG010
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Year 5
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      89
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      38
    5. group Id
      OG004
      value
      50
    6. group Id
      OG005
      value
      26
    7. group Id
      OG006
      value
      49
    8. group Id
      OG007
      value
      30
    9. group Id
      OG008
      value
      36
    10. group Id
      OG009
      value
      28
    11. group Id
      OG010
      value
      24
    units
    Participants
description
The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray's method. NA = not estimable. One year = 12 months.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    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
    OG005
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG006
    title
    Bosutinib 500 mg, AP-CML IM R/I (Part 2)
  8. description
    Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG007
    title
    Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG008
    title
    Bosutinib 500 mg, BP-CML IM R/I (Part 2)
  10. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG009
    title
    Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
  11. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    OG010
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
param Type
NUMBER
population Description
All-treated population included all enrolled participants who received at least one dose of study medication.
reporting Status
POSTED
time Frame
Years 1, 2, 3, 4, and 5 (CP2L only)
title
Cumulative Incidence of Progression/Death - Part 2
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice