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NCT04971226 · OUTCOME

PK of Asciminib: AUCtau and AUClast

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Source last updated 2026-08-28

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

Measure
GEOMETRIC_MEAN
Unit
ng*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)

What was measured

AUCtau is the area under the plasma concentration-time curve over the dosing interval. AUClast is the area under the plasma concentration-time curve from time zero (time of dose administration) to time of last measurable concentration (mass x time x volume-1)

Analysis population: Full PK samples were collected at Week 2. Although samples were collected for 26 participants, AUCtau could not be evaluated because extrapolated AUC was over 20% for all participants. AUCtau is derived from extrapolated AUC. However, when it is over 20% for all participants, AUCtau cannot be determined.

Groups in this outcome

Asciminib (All Asciminib)

Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.

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

Analysis denominator · Participants

GroupSource count
Asciminib (All Asciminib)26

Reported measurements

AUClast
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)859042.2Not reportedNot reportedNot reported
AUCtau
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)NANANot reportedNot reportedAlthough samples were collected for 26 participants, AUCtau could not be evaluated because extrapolated AUC was over 20% for all participants. AUCtau is derived from extrapolated AUC. However, when it is over 20% for all participants, AUCtau cannot be determined.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.2
        value
        8590
    title
    AUClast
  2. categories
    1. measurements
      1. comment
        Although samples were collected for 26 participants, AUCtau could not be evaluated because extrapolated AUC was over 20% for all participants. AUCtau is derived from extrapolated AUC. However, when it is over 20% for all participants, AUCtau cannot be determined.
        group Id
        OG000
        spread
        NA
        value
        NA
    title
    AUCtau
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
AUCtau is the area under the plasma concentration-time curve over the dosing interval. AUClast is the area under the plasma concentration-time curve from time zero (time of dose administration) to time of last measurable concentration (mass x time x volume-1)
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
    id
    OG000
    title
    Asciminib (All Asciminib)
param Type
GEOMETRIC_MEAN
population Description
Full PK samples were collected at Week 2. Although samples were collected for 26 participants, AUCtau could not be evaluated because extrapolated AUC was over 20% for all participants. AUCtau is derived from extrapolated AUC. However, when it is over 20% for all participants, AUCtau cannot be determined.
reporting Status
POSTED
time Frame
Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)
title
PK of Asciminib: AUCtau and AUClast
type
SECONDARY
unit Of Measure
ng*hr/mL

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

Preserved source evidence · Not medical advice