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NCT02130557 · OUTCOME

Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) 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
nanogram per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on Days 28, 56 and 84

What was measured

CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.

Analysis population: Pharmacokinetic (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 "number analyzed (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
Bosutinib191

Reported measurements

Day 28

Analysis denominator · Participants

GroupSource count
Bosutinib181
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib71.28246.0545Not reportedNot reportedNot reported
Day 56

Analysis denominator · Participants

GroupSource count
Bosutinib184
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib73.06945.1349Not reportedNot reportedNot reported
Day 84

Analysis denominator · Participants

GroupSource count
Bosutinib184
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bosutinib83.97364.3206Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.0545
        value
        71.282
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      units
      Participants
    title
    Day 28
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.1349
        value
        73.069
    denoms
    1. counts
      1. group Id
        OG000
        value
        184
      units
      Participants
    title
    Day 56
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.3206
        value
        83.973
    denoms
    1. counts
      1. group Id
        OG000
        value
        184
      units
      Participants
    title
    Day 84
denoms
  1. counts
    1. group Id
      OG000
      value
      191
    units
    Participants
description
CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.
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
Pharmacokinetic (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 "number analyzed (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 Complete Cytogenetic Response (CCyR) of Bosutinib
type
OTHER_PRE_SPECIFIED
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice