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NCT02130557 · OUTCOME

Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia · Source last updated 2021-05-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on Days 28, 56 and 84

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.

Analysis population: PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.

Groups in this outcome

Bosutinib

Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Bosutinib177

Reported measurements

Day 28: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib177
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib69.40255.5005Not reportedNot reportedNot reported
Day 28: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib60
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib63.52940.9949Not reportedNot reportedNot reported
Day 28: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib84
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib74.77960.6257Not reportedNot reportedNot reported
Day 28: Nausea

Analysis denominator · Participants

GroupSource count
Bosutinib86
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib66.01142.6437Not reportedNot reportedNot reported
Day 28: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib44
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib71.68460.7208Not reportedNot reportedNot reported
Day 56: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib172
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib68.83442.6621Not reportedNot reportedNot reported
Day 56: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib61
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib65.32743.2859Not reportedNot reportedNot reported
Day 56: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib84
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib70.01638.7506Not reportedNot reportedNot reported
Day 56: Nausea

Analysis denominator · Participants

GroupSource count
Bosutinib85
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib61.62644.4007Not reportedNot reportedNot reported
Day 56: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib40
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib65.98045.9064Not reportedNot reportedNot reported
Day 84: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib165
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib81.26964.6462Not reportedNot reportedNot reported
Day 84: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib63
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib71.58533.6674Not reportedNot reportedNot reported
Day 84: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib85
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib89.08069.5237Not reportedNot reportedNot reported
Day 84: Nausea

Analysis denominator · Participants

GroupSource count
Bosutinib80
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib77.70261.6179Not reportedNot reportedNot reported
Day 84: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib41
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib86.94955.3041Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.5005
        value
        69.402
    denoms
    1. counts
      1. group Id
        OG000
        value
        177
      units
      Participants
    title
    Day 28: Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.9949
        value
        63.529
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Day 28: Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.6257
        value
        74.779
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      units
      Participants
    title
    Day 28: Rash
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.6437
        value
        66.011
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Day 28: Nausea
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.7208
        value
        71.684
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Day 28: Vomiting
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.6621
        value
        68.834
    denoms
    1. counts
      1. group Id
        OG000
        value
        172
      units
      Participants
    title
    Day 56: Diarrhea
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.2859
        value
        65.327
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Day 56: Thrombocytopenia
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.7506
        value
        70.016
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      units
      Participants
    title
    Day 56: Rash
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.4007
        value
        61.626
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Day 56: Nausea
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.9064
        value
        65.980
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      units
      Participants
    title
    Day 56: Vomiting
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.6462
        value
        81.269
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      units
      Participants
    title
    Day 84: Diarrhea
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.6674
        value
        71.585
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Day 84: Thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      177
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    OG000
    title
    Bosutinib
param Type
MEAN
population Description
PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.
reporting Status
POSTED
time Frame
Pre-dose on Days 28, 56 and 84
title
Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib
type
OTHER_PRE_SPECIFIED
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice