Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00261846 · OUTCOME

Kaplan-Meier Estimate of Overall Survival (OS) - 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

OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored. NA = not estimable. One year = 12 months.

Analysis population: All-treated population included all enrolled participants who received at least 1 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)96.3Not reported92.598.2Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)98.9Not reported92.199.8Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)100Not reported100100Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)85.8Not reported69.293.8Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)91.8Not reported79.796.6Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)96.2Not reported75.799.4Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)81.3Not reported67.289.8Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)72.9Not reported53.085.4Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)44.3Not reported27.459.9Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)39.3Not reported21.756.5Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)16.7Not reported5.233.7Not reported
Year 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)88.2Not reported82.792.1Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)97.7Not reported91.099.4Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)80.0Not reported20.496.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)79.7Not reported62.089.8Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)83.3Not reported69.391.3Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)92.3Not reported72.698.0Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)72.7Not reported57.683.1Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)59.0Not reported39.274.3Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)41.3Not reported24.957.0Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)25.0Not reported11.141.8Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reported1.423.3Not reported
Year 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)84.1Not reported77.888.7Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)93.0Not reported83.997.1Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)80.0Not reported20.496.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)66.1Not reported44.580.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)83.3Not reported69.391.3Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)86.5Not reported62.995.6Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)70.1Not reported54.781.1Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)45.1Not reported25.463.0Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)41.3Not reported24.957.0Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)16.7Not reported5.632.9Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reported1.423.3Not reported
Year 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)81.5Not reported74.786.6Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)93.0Not reported83.997.1Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)80.0Not reported20.496.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)66.1Not reported44.580.9Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)79.3Not reported63.189.0Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)86.5Not reported62.995.6Not reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)65.7Not reported48.678.3Not reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)45.1Not reported25.463.0Not reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)20.7Not reported2.053.2Not reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)16.7Not reported5.632.9Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reported1.423.3Not reported
Year 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)80.6Not reported73.685.9Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)88.4Not reported76.694.5Not 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
        92.5
        upper Limit
        98.2
        value
        96.3
      2. group Id
        OG001
        lower Limit
        92.1
        upper Limit
        99.8
        value
        98.9
      3. group Id
        OG002
        lower Limit
        100
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        69.2
        upper Limit
        93.8
        value
        85.8
      5. group Id
        OG004
        lower Limit
        79.7
        upper Limit
        96.6
        value
        91.8
      6. group Id
        OG005
        lower Limit
        75.7
        upper Limit
        99.4
        value
        96.2
      7. group Id
        OG006
        lower Limit
        67.2
        upper Limit
        89.8
        value
        81.3
      8. group Id
        OG007
        lower Limit
        53.0
        upper Limit
        85.4
        value
        72.9
      9. group Id
        OG008
        lower Limit
        27.4
        upper Limit
        59.9
        value
        44.3
      10. group Id
        OG009
        lower Limit
        21.7
        upper Limit
        56.5
        value
        39.3
      11. group Id
        OG010
        lower Limit
        5.2
        upper Limit
        33.7
        value
        16.7
    title
    Year 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.7
        upper Limit
        92.1
        value
        88.2
      2. group Id
        OG001
        lower Limit
        91.0
        upper Limit
        99.4
        value
        97.7
      3. group Id
        OG002
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80.0
      4. group Id
        OG003
        lower Limit
        62.0
        upper Limit
        89.8
        value
        79.7
      5. group Id
        OG004
        lower Limit
        69.3
        upper Limit
        91.3
        value
        83.3
      6. group Id
        OG005
        lower Limit
        72.6
        upper Limit
        98.0
        value
        92.3
      7. group Id
        OG006
        lower Limit
        57.6
        upper Limit
        83.1
        value
        72.7
      8. group Id
        OG007
        lower Limit
        39.2
        upper Limit
        74.3
        value
        59.0
      9. group Id
        OG008
        lower Limit
        24.9
        upper Limit
        57.0
        value
        41.3
      10. group Id
        OG009
        lower Limit
        11.1
        upper Limit
        41.8
        value
        25.0
      11. group Id
        OG010
        lower Limit
        1.4
        upper Limit
        23.3
        value
        8.3
    title
    Year 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.8
        upper Limit
        88.7
        value
        84.1
      2. group Id
        OG001
        lower Limit
        83.9
        upper Limit
        97.1
        value
        93.0
      3. group Id
        OG002
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80.0
      4. group Id
        OG003
        lower Limit
        44.5
        upper Limit
        80.9
        value
        66.1
      5. group Id
        OG004
        lower Limit
        69.3
        upper Limit
        91.3
        value
        83.3
      6. group Id
        OG005
        lower Limit
        62.9
        upper Limit
        95.6
        value
        86.5
      7. group Id
        OG006
        lower Limit
        54.7
        upper Limit
        81.1
        value
        70.1
      8. group Id
        OG007
        lower Limit
        25.4
        upper Limit
        63.0
        value
        45.1
      9. group Id
        OG008
        lower Limit
        24.9
        upper Limit
        57.0
        value
        41.3
      10. group Id
        OG009
        lower Limit
        5.6
        upper Limit
        32.9
        value
        16.7
      11. group Id
        OG010
        lower Limit
        1.4
        upper Limit
        23.3
        value
        8.3
    title
    Year 3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.7
        upper Limit
        86.6
        value
        81.5
      2. group Id
        OG001
        lower Limit
        83.9
        upper Limit
        97.1
        value
        93.0
      3. group Id
        OG002
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80.0
      4. group Id
        OG003
        lower Limit
        44.5
        upper Limit
        80.9
        value
        66.1
      5. group Id
        OG004
        lower Limit
        63.1
        upper Limit
        89.0
        value
        79.3
      6. group Id
        OG005
        lower Limit
        62.9
        upper Limit
        95.6
        value
        86.5
      7. group Id
        OG006
        lower Limit
        48.6
        upper Limit
        78.3
        value
        65.7
      8. group Id
        OG007
        lower Limit
        25.4
        upper Limit
        63.0
        value
        45.1
      9. group Id
        OG008
        lower Limit
        2.0
        upper Limit
        53.2
        value
        20.7
      10. group Id
        OG009
        lower Limit
        5.6
        upper Limit
        32.9
        value
        16.7
      11. group Id
        OG010
        lower Limit
        1.4
        upper Limit
        23.3
        value
        8.3
    title
    Year 4
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.6
        upper Limit
        85.9
        value
        80.6
      2. group Id
        OG001
        lower Limit
        76.6
        upper Limit
        94.5
        value
        88.4
      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
OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored. 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 1 dose of study medication.
reporting Status
POSTED
time Frame
Years 1, 2, 3, 4, and 5 (CP2L only)
title
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice