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NCT00261846 · OUTCOME

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
MEDIAN
Unit
Months
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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)NANot reportedNANAKM estimate at Year 5 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)81.5Not reported81.5NAThe upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reported21.0NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)NANot reported34.4NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)NANot reported68.5NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)NANot reportedNANAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, AP-CML IM R/I (Part 2)NANot reportedNANAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)33.4Not reported14.6NAThe upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, BP-CML IM R/I (Part 2)11.2Not reported9.4NAThe upper 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)8.9Not reported4.117.4Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3.6Not reported1.37.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        KM estimate at Year 5 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG001
        lower Limit
        81.5
        upper Limit
        NA
        value
        81.5
      3. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG002
        lower Limit
        21.0
        upper Limit
        NA
        value
        NA
      4. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG003
        lower Limit
        34.4
        upper Limit
        NA
        value
        NA
      5. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG004
        lower Limit
        68.5
        upper Limit
        NA
        value
        NA
      6. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      8. comment
        The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG007
        lower Limit
        14.6
        upper Limit
        NA
        value
        33.4
      9. comment
        The upper 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG008
        lower Limit
        9.4
        upper Limit
        NA
        value
        11.2
      10. group Id
        OG009
        lower Limit
        4.1
        upper Limit
        17.4
        value
        8.9
      11. group Id
        OG010
        lower Limit
        1.3
        upper Limit
        7.6
        value
        3.6
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
MEDIAN
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
Overall Survival (OS) - Part 2
type
SECONDARY
unit Of Measure
Months

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