Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02130557 · OUTCOME

Summary of Trough Plasma Concentration by Presence of Grade 3 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 NCI 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 3 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
Bosutinib24

Reported measurements

Day 28: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib19
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib87.769102.6181Not reportedNot reportedNot reported
Day 28: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib23
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib49.22036.3461Not reportedNot reportedNot reported
Day 28: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib71.15043.3246Not reportedNot reportedNot reported
Day 28: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib3
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib14.66321.5799Not reportedNot reportedNot reported
Day 56: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib16
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib68.51345.2672Not reportedNot reportedNot reported
Day 56: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib24
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib56.85334.3892Not reportedNot reportedNot reported
Day 56: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib58.92518.8656Not reportedNot reportedNot reported
Day 56: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib38.200NANot reportedNot reportedAs only 1 participant was analyzed, standard deviation could not be calculated.
Day 84: Diarrhea

Analysis denominator · Participants

GroupSource count
Bosutinib17
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib76.78246.3006Not reportedNot reportedNot reported
Day 84: Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Bosutinib23
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib67.62335.3084Not reportedNot reportedNot reported
Day 84: Rash

Analysis denominator · Participants

GroupSource count
Bosutinib3
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib83.96719.2542Not reportedNot reportedNot reported
Day 84: Vomiting

Analysis denominator · Participants

GroupSource count
Bosutinib1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib12.400NANot reportedNot reportedAs only 1 participant was analyzed, standard deviation could not be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        102.6181
        value
        87.769
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Day 28: Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.3461
        value
        49.220
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Day 28: Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.3246
        value
        71.150
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 28: Rash
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.5799
        value
        14.663
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Day 28: Vomiting
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.2672
        value
        68.513
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Day 56: Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.3892
        value
        56.853
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Day 56: Thrombocytopenia
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.8656
        value
        58.925
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 56: Rash
  8. categories
    1. measurements
      1. comment
        As only 1 participant was analyzed, standard deviation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        38.200
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 56: Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.3006
        value
        76.782
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Day 84: Diarrhea
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.3084
        value
        67.623
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Day 84: Thrombocytopenia
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.2542
        value
        83.967
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Day 84: Rash
  12. categories
    1. measurements
      1. comment
        As only 1 participant was analyzed, standard deviation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        12.400
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 84: Vomiting
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    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 NCI 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 3 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 3 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