Trial Outcomes & Findings for A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP (NCT NCT04971226)

Last Updated: 2025-11-21

Results Overview

Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

406 participants

Primary outcome timeframe

At 48 weeks

Results posted on

2025-11-21

Participant Flow

All trial participants randomized in a 1:1 ratio between asciminib and investigator selected TKI (imatinib 400 mg QD, nilotinib 300 mg BD, dasatinib 100 mg QD or bosutinib 400 mg QD).

Prior to randomization, the Investigator, in consultation with the participant, considering current treatment paradigm and participant characteristics - and comorbidities, made a selection of imatinib or 2G TKI (nilotinib, dasatinib, or bosutinib) to be used if the participant is randomized to the comparator arm. The enrolment into the strata of imatinib versus 2G TKI was managed by IRT to be approximately 50% versus 50%.

Participant milestones

Participant milestones
Measure	Asciminib (Imatinib Stratum) Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Asciminib (2nd Generation TKI Stratum) Patients took ascimimib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (Imatinib Stratum) Patients took on ongoing basis the Investigator selected TKI (imatinib)	Investigator Selected TKI (2nd Generation TKI Stratum Patients took on ongoing basis the 2G investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)
Overall Study STARTED	101	100	102	102
Overall Study Participants Not Treated	1	0	2	1
Overall Study Treated	100	100	100	101
Overall Study COMPLETED	85	88	63	77
Overall Study NOT COMPLETED	16	12	39	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Asciminib (Imatinib Stratum) Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Asciminib (2nd Generation TKI Stratum) Patients took ascimimib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (Imatinib Stratum) Patients took on ongoing basis the Investigator selected TKI (imatinib)	Investigator Selected TKI (2nd Generation TKI Stratum Patients took on ongoing basis the 2G investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)
Overall Study Unsatisfactory therapeutic effect	6	6	21	10
Overall Study Adverse Event	6	5	11	10
Overall Study Progressive disease	2	0	3	1
Overall Study Protocol Deviation	1	0	1	1
Overall Study Subject Decision	0	1	1	1
Overall Study Pregnancy	0	0	0	1
Overall Study Participants not treated	1	0	2	1

Baseline Characteristics

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asciminib (Imatinib Stratum) n=101 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Asciminib (2nd Generation TKI Stratum) n=100 Participants Patients took ascimimib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (Imatinib Stratum) n=102 Participants Patients took on ongoing basis the Investigator selected TKI (imatinib)	Investigator Selected TKI (2nd Generation TKI Stratum) n=102 Participants Patients took on ongoing basis the 2G investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)	Total n=405 Participants Total of all reporting groups
Age, Customized 18 to <65 years	69 Participants n=68 Participants	86 Participants n=76 Participants	70 Participants n=48 Participants	85 Participants n=33 Participants	310 Participants n=225 Participants
Age, Customized 65 to <75 years	24 Participants n=68 Participants	12 Participants n=76 Participants	22 Participants n=48 Participants	12 Participants n=33 Participants	70 Participants n=225 Participants
Age, Customized >= 75 years	8 Participants n=68 Participants	2 Participants n=76 Participants	10 Participants n=48 Participants	5 Participants n=33 Participants	25 Participants n=225 Participants
Sex: Female, Male Female	39 Participants n=68 Participants	31 Participants n=76 Participants	37 Participants n=48 Participants	42 Participants n=33 Participants	149 Participants n=225 Participants
Sex: Female, Male Male	62 Participants n=68 Participants	69 Participants n=76 Participants	65 Participants n=48 Participants	60 Participants n=33 Participants	256 Participants n=225 Participants
Race/Ethnicity, Customized White	63 Participants n=68 Participants	45 Participants n=76 Participants	66 Participants n=48 Participants	44 Participants n=33 Participants	218 Participants n=225 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=68 Participants	1 Participants n=76 Participants	1 Participants n=48 Participants	1 Participants n=33 Participants	4 Participants n=225 Participants
Race/Ethnicity, Customized Asian	37 Participants n=68 Participants	53 Participants n=76 Participants	34 Participants n=48 Participants	56 Participants n=33 Participants	180 Participants n=225 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=68 Participants	1 Participants n=76 Participants	1 Participants n=48 Participants	1 Participants n=33 Participants	3 Participants n=225 Participants
EUTOS Long-Term Survival (ELTS) score Low	62 Participants n=68 Participants	60 Participants n=76 Participants	64 Participants n=48 Participants	61 Participants n=33 Participants	247 Participants n=225 Participants
EUTOS Long-Term Survival (ELTS) score Intermediate	30 Participants n=68 Participants	26 Participants n=76 Participants	30 Participants n=48 Participants	27 Participants n=33 Participants	113 Participants n=225 Participants
EUTOS Long-Term Survival (ELTS) score High	9 Participants n=68 Participants	14 Participants n=76 Participants	8 Participants n=48 Participants	14 Participants n=33 Participants	45 Participants n=225 Participants

PRIMARY outcome

Timeframe: At 48 weeks

Population: The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization.

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=201 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) n=204 Participants Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI	136 Participants	100 Participants

PRIMARY outcome

Timeframe: At 48 weeks

Population: The IMA Full Analysis Set (FASIMA) comprised of all participants from the FAS, whose PRS TKI is imatinib. FAS comprised of all participants to whom study treatment has been assigned by randomization.

Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=101 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) n=102 Participants Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)	70 Participants	41 Participants

SECONDARY outcome

Timeframe: at 96 weeks (96 weeks after last patient first dose)

Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after last patient first dose

TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to Adverse Event (AE). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count \< 10 x 10\^9/L PLT count \< 450 x 10\^9/L Basophils \< 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes \< 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported later

Population: The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization and who had a valid bone marrow examination at week 48.

The CCyR response status was to be based on bone marrow assessment. Bone marrow examination for cytogenetic assessment was to be performed locally by the Investigator at baseline for all participants. Thereafter, during the course of the study, cytogenetic assessment was not mandatory and only performed if clinically indicated.

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=2 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 Complete cytogenetic response (CCyR)	1 Participants	0 Participants
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 Partial cytogenetic response (PCyR)	1 Participants	0 Participants
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 Minor cytogenetic response (mCyR)	0 Participants	0 Participants
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 Minimal cytogenetic response	0 Participants	0 Participants
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 No cytogenetic response	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Duration of MMR is defined as the time between the date of the first documented achievement of MMR and the earliest date of loss of MMR, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Duration of MR4.0 is defined as the time between the date of the first documented achievement of MR4.0 and the earliest date of loss of MR4.0, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Duration of MR4.5 is defined as the time between the date of the first documented achievement of MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MMR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.0. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.5.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: treatment failure as per ELN, Confirmed loss of MMR while on study treatment, discontinuation from study treatment due to any reason For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the last study assessment date while on treatment, or the EOT (whichever comes first) .

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

FFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure per ELN, confirmed loss of MMR, progression to AP/BC, death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

EFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure as per ELN, confirmed loss of MMR ,discontinuation of study treatment due to AE, progression to AP/BC, death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned total follow-up duration of 5 years

OS is defined as the time from the date of randomization to the date of death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last contact before the cut-off date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: Pharmacokinetic analysis set (PAS): All participants to whom study treatment has been assigned by randomization to asciminib and that had a valid trough plasma concentration taken at week 48.

Trough plasma concentration will measure the concentration of asciminib in the blood immediately before the next dose is administered.

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=107 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Trough Plasma Concentrations.	161 ng/mL Interval 11.9 to 1010.0	—

SECONDARY outcome

Timeframe: Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)

Population: Full PK samples were collected at Week 2

Cmax is the maximum serum concentration of asciminib during a dosing interval (mass x volume-1).

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=26 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Pharmacokinetics (PK) of Asciminib: Cmax	1470 ng/mL Geometric Coefficient of Variation 38.2	—

SECONDARY outcome

Timeframe: Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)

Population: Full PK samples were collected at Week 2

Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time)

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=26 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
PK of Asciminib: Tmax	2.00 Hour (hr) Interval 0.883 to 3.18	—

SECONDARY outcome

Timeframe: Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)

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.

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)

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=26 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
PK of Asciminib: AUCtau and AUClast AUClast	8590 ng*hr/mL Geometric Coefficient of Variation 42.2	—
PK of Asciminib: AUCtau and AUClast AUCtau	NA ng*hr/mL Geometric Coefficient of Variation NA 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.	—

SECONDARY outcome

Timeframe: Week 2 (0 hours (h) pre-dose, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose)

Population: Although samples were collected for 26 participants, CL/F could not be evaluated because extrapolated AUC was over 20% for all participants. CL/F is derived from extrapolated AUC. However, when it is over 20% for all participants, CL/F cannot be determined.

CL/F is the apparent total body clearance of asciminib from plasma after oral administration (volume x time-1).

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=26 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
PK of Asciminib: CL/F	NA ng*hr/mL Geometric Coefficient of Variation NA Although samples were collected for 26 participants, CL/F could not be evaluated because extrapolated AUC was over 20% for all participants. CL/F is derived from extrapolated AUC. However, when it is over 20% for all participants, CL/F cannot be determined.	—

SECONDARY outcome

Timeframe: Baseline, week 48 and week 96

Population: Full Analysis Set: All participants who had an EORTC QLQ-C30 assessment both at baseline and at week 48.

The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses the quality of life of cancer patients. It consists of functioning scales, symptom scales, and the global health status quality of life (QoL) scale. A high score for functional and QoL items/scales from the QLQ-30 represents better function and QOL. A high score in symptoms items from QLQ-30 represents worse symptoms.

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=79 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) n=70 Participants Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · Very much better	10 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · Moderately better	18 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · A little better	6 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · Unchanged	28 Participants	26 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · A little worse	5 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · Moderately worse	10 Participants	12 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Global health status/QoL · Very much worse	2 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · Very much better	3 Participants	3 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · Moderately better	10 Participants	12 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · A little better	16 Participants	12 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · Unchanged	32 Participants	26 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · A little worse	7 Participants	8 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · Moderately worse	10 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Physical functioning · Very much worse	1 Participants	3 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · Very much better	5 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · Moderately better	10 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · Unchanged	54 Participants	41 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · Moderately worse	4 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Role functioning · Very much worse	6 Participants	8 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · Very much better	9 Participants	10 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · Moderately better	7 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · A little better	14 Participants	9 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · Unchanged	31 Participants	24 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · A little worse	7 Participants	10 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · Moderately worse	5 Participants	5 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Emotional functioning · Very much worse	6 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · Very much better	3 Participants	1 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · Moderately better	13 Participants	8 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · Unchanged	44 Participants	36 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · Moderately worse	16 Participants	19 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Cognitive functioning · Very much worse	3 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · Very much better	7 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · Moderately better	14 Participants	6 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · Unchanged	51 Participants	40 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · Moderately worse	4 Participants	7 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Social functioning · Very much worse	3 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · Very much better	19 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · Moderately better	16 Participants	16 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · Unchanged	26 Participants	16 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · Moderately worse	11 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Fatigue · Very much worse	7 Participants	16 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · Very much better	1 Participants	1 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · Moderately better	7 Participants	5 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · Unchanged	67 Participants	48 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · Moderately worse	3 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Nausea and vomiting · Very much worse	1 Participants	5 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · Very much better	9 Participants	3 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · Moderately better	17 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · Unchanged	45 Participants	37 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · Moderately worse	5 Participants	10 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Pain · Very much worse	3 Participants	9 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · Very much better	11 Participants	9 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · Unchanged	59 Participants	49 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Dyspnoea · Very much worse	9 Participants	12 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · Very much better	14 Participants	10 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · Unchanged	50 Participants	43 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Insomnia · Very much worse	15 Participants	17 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · Very much better	16 Participants	11 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · Unchanged	59 Participants	51 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Appetite loss · Very much worse	4 Participants	8 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · Very much better	8 Participants	14 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · Unchanged	58 Participants	40 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Constipation · Very much worse	13 Participants	16 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · Very much better	11 Participants	8 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · Unchanged	61 Participants	43 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Diarrhoea · Very much worse	7 Participants	19 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · Very much better	12 Participants	14 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · Moderately better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · A little better	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · Unchanged	63 Participants	49 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · A little worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · Moderately worse	0 Participants	0 Participants
Change From Baseline in Overall Scores (Global Health Status) and Individual Scales of the EORTC QLQ-C30 at Week 48 and Week 96 Financial difficulties · Very much worse	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, week 48 and week 96.

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

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.

Outcome measures

Outcome measures
Measure	Asciminib (All Asciminib ) n=77 Participants Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.	Investigator Selected TKI (All Comparators) n=66 Participants Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · Unchanged	48 Participants	41 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · Very much better	0 Participants	2 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · Moderately better	12 Participants	4 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · A little better	18 Participants	5 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · Unchanged	27 Participants	22 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · A little worse	7 Participants	16 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · Moderately worse	6 Participants	12 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Symptom Burden · Very much worse	7 Participants	5 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · Very much better	11 Participants	7 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · Moderately better	7 Participants	9 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · A little better	20 Participants	6 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · Unchanged	17 Participants	18 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · A little worse	16 Participants	11 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · Moderately worse	2 Participants	4 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Worry/Mood · Very much worse	4 Participants	11 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · Very much better	21 Participants	17 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · Moderately better	26 Participants	10 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · A little better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · Unchanged	19 Participants	23 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · A little worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · Moderately worse	6 Participants	5 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Impact on Daily Life · Very much worse	5 Participants	11 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · Very much better	18 Participants	10 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · Moderately better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · A little better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · A little worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · Moderately worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Body Image Problems · Very much worse	11 Participants	15 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · Very much better	8 Participants	13 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · Moderately better	5 Participants	4 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · A little better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · Unchanged	30 Participants	31 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · A little worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · Moderately worse	18 Participants	7 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Care and Information · Very much worse	16 Participants	11 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · Very much better	15 Participants	14 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · Moderately better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · A little better	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · Unchanged	40 Participants	37 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · A little worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · Moderately worse	0 Participants	0 Participants
Change From Baseline in EORTC QLQ-CML24 Scales at Week 48 and Week 96 Satisfaction with Social Life · Very much worse	22 Participants	15 Participants

Adverse Events

Asciminib (All Asciminib)

Serious events: 22 serious events

Other events: 177 other events

Deaths: 0 deaths

Imatinib

Serious events: 12 serious events

Other events: 89 other events

Deaths: 0 deaths

2nd Generation TKI

Serious events: 20 serious events

Other events: 100 other events

Deaths: 0 deaths

All Comparators

Serious events: 32 serious events

Other events: 189 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: 862-778-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER