Skip to content
← Full study record

NCT04971226 · OUTCOME

Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, week 48 and week 96.

What was measured

The QLQ-CML24 consists of multi-scale items: symptom burden, impact on worry/mood, impact on daily life, body image problems, satisfaction with care and information and satisfaction with social life. A higher score on most of the item scales in QLQ-CML24 reflects a larger impairment in the corresponding domain, with the exception of the satisfaction with care and information, and problems and satisfaction with social life, where a higher score reflects a higher level of satisfaction.

Analysis population: Full Analysis Set: All participants who had an EORTC QLQ-CML24 assessment both at baseline and at week 48.

Groups in this outcome

Asciminib (All Asciminib)

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

Investigator Selected TKI (All Comparators)

Patients will take on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)

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)77
Investigator Selected TKI (All Comparators)66

Reported measurements

Symptom Burden

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)2Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)12Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)4Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)18Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)5Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)27Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)22Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)7Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)16Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)6Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)12Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)7Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)5Not reportedNot reportedNot reportedNot reported
Impact on Worry/Mood

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)11Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)7Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)7Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)9Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)20Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)6Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)17Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)18Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)16Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)11Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)2Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)4Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)4Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)11Not reportedNot reportedNot reportedNot reported
Impact on Daily Life

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)21Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)17Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)26Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)10Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)19Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)23Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)6Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)5Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)5Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)11Not reportedNot reportedNot reportedNot reported
Body Image Problems

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)18Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)10Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)48Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)41Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)11Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)15Not reportedNot reportedNot reportedNot reported
Satisfaction with Care and Information

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)8Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)13Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)5Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)4Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)30Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)31Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)18Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)7Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)16Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)11Not reportedNot reportedNot reportedNot reported
Satisfaction with Social Life

Very much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)15Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)14Not reportedNot reportedNot reportedNot reported

Moderately better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Unchanged

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)40Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)37Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Moderately worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Very much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib)22Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        5
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        22
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        16
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        12
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      title
      Very much worse
    title
    Symptom Burden
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        6
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        18
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        11
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        11
      title
      Very much worse
    title
    Impact on Worry/Mood
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        17
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        10
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        23
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        11
      title
      Very much worse
    title
    Impact on Daily Life
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        10
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        41
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        15
      title
      Very much worse
    title
    Body Image Problems
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        31
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        7
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        11
      title
      Very much worse
    title
    Satisfaction with Care and Information
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        14
      title
      Very much better
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Moderately better
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little better
    4. measurements
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        37
      title
      Unchanged
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      A little worse
    6. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Moderately worse
    7. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        15
      title
      Very much worse
    title
    Satisfaction with Social Life
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      66
    units
    Participants
description
The QLQ-CML24 consists of multi-scale items: symptom burden, impact on worry/mood, impact on daily life, body image problems, satisfaction with care and information and satisfaction with social life. A higher score on most of the item scales in QLQ-CML24 reflects a larger impairment in the corresponding domain, with the exception of the satisfaction with care and information, and problems and satisfaction with social life, where a higher score reflects a higher level of satisfaction.
groups
  1. description
    Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
    id
    OG000
    title
    Asciminib (All Asciminib)
  2. description
    Patients will take on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
    id
    OG001
    title
    Investigator Selected TKI (All Comparators)
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set: All participants who had an EORTC QLQ-CML24 assessment both at baseline and at week 48.
reporting Status
POSTED
time Frame
Baseline, week 48 and week 96.
title
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice