Trial Outcomes & Findings for Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs (NCT NCT03106779)

NCT ID: NCT03106779

Last Updated: 2025-04-08

Results Overview

MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by IS as measured by RQ-PCR.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 233 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2025-04-08

Participant Flow

Approximately 220 patients were planned to be enrolled, and 233 patients (157 randomized to treatment with asciminib and 76 to treatment with bosutinib) were enrolled and analyzed

Randomization was stratified by major cytogenetic response (MCyR) at screening.

Participant milestones

Measure	Asciminib Patients randomized to asciminib 40mg BID	Bosutinib Patients randomized to bosutinib 500mg QD
Overall Study STARTED	157	76
Overall Study Treated	156	0
Overall Study Not Treated	1	0
Overall Study COMPLETED	97	22
Overall Study NOT COMPLETED	60	54

Reasons for withdrawal

Measure	Asciminib Patients randomized to asciminib 40mg BID	Bosutinib Patients randomized to bosutinib 500mg QD
Overall Study Lack of Efficacy	33	24
Overall Study Adverse Event	8	16
Overall Study Physician Decision	10	6
Overall Study Patient/guardian decision	4	3
Overall Study Progressive disease	1	3
Overall Study Lost to Follow-up	1	2
Overall Study Death	1	0
Overall Study Protocol Violation	1	0
Overall Study Not treated	1	0

Baseline Characteristics

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

Baseline characteristics by cohort

Measure	Asciminib n=157 Participants Patients randomized to asciminib 40mg BID	Bosutinib n=76 Participants Patients randomized to bosutinib 500mg QD	Total n=233 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 13.49 • n=93 Participants	51.0 years STANDARD_DEVIATION 13.95 • n=4 Participants	51.0 years STANDARD_DEVIATION 13.61 • n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	45 Participants n=4 Participants	120 Participants n=27 Participants
Sex: Female, Male Male	82 Participants n=93 Participants	31 Participants n=4 Participants	113 Participants n=27 Participants
Race/Ethnicity, Customized White	118 participants n=93 Participants	56 participants n=4 Participants	174 participants n=27 Participants
Race/Ethnicity, Customized Asian	22 participants n=93 Participants	11 participants n=4 Participants	33 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	8 participants n=93 Participants	2 participants n=4 Participants	10 participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Other	5 participants n=93 Participants	7 participants n=4 Participants	12 participants n=27 Participants
Race/Ethnicity, Customized Unknown	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Full Analysis Set (FAS): The FAS comprised of all randomized patients.

MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by IS as measured by RQ-PCR.

Outcome measures

Measure	Asciminib n=157 Participants Patients randomized to asciminib 40mg BID	Bosutinib n=76 Participants Patients randomized to bosutinib 500mg QD
Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks	40 Participants	10 Participants

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib. Cytogenic response will include Complete, Partial, Major, Minor, Minimal and no response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To compare additional parameters of the efficacy of asciminib versus bosutinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To characterize the PK of asciminib in the CML-CP population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To characterize the PK of asciminib in the CML-CP population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To characterize the PK of asciminib in the CML-CP population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To characterize the PK of asciminib in the CML-CP population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks after the last patient received the first study dose

To characterize the PK of asciminib in the CML-CP population

Outcome measures

Outcome data not reported

Adverse Events

Asciminib

Serious events: 21 serious events

Other events: 122 other events

Deaths: 4 deaths

Bosutinib

Serious events: 14 serious events

Other events: 69 other events

Deaths: 1 deaths

Serious adverse events

Measure	Asciminib n=156 participants at risk Patients randomized to asciminib 40mg BID	Bosutinib n=76 participants at risk Patients randomized to bosutinib 500mg QD
Blood and lymphatic system disorders Febrile neutropenia	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Cardiac disorders Cardiac failure	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Cardiac disorders Myocardial ischaemia	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Eye disorders Toxic optic neuropathy	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Mesenteric artery embolism	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Mesenteric artery thrombosis	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Subileus	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Hyperthermia	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Pyrexia	1.3% 2/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations COVID-19	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Mycobacterium avium complex infection	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Postoperative wound infection	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Septic shock	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Ejection fraction decreased	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Platelet count decreased	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Headache	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Hemiparesis	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Ischaemic stroke	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Product Issues Device malfunction	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Psychiatric disorders Anxiety	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Psychiatric disorders Depression	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Psychiatric disorders Major depression	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	2.6% 2/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Vascular disorders Angiopathy	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Vascular disorders Aortic occlusion	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Vascular disorders Haematoma	0.64% 1/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.

Other adverse events

Measure	Asciminib n=156 participants at risk Patients randomized to asciminib 40mg BID	Bosutinib n=76 participants at risk Patients randomized to bosutinib 500mg QD
Blood and lymphatic system disorders Anaemia	9.6% 15/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	7.9% 6/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	17.9% 28/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	17.1% 13/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	22.4% 35/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	13.2% 10/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	4.5% 7/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	14.5% 11/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	4.5% 7/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	6.6% 5/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	5.1% 8/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	11.5% 18/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	71.1% 54/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	5.1% 8/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	3.9% 3/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	11.5% 18/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	46.1% 35/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	7.1% 11/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	25.0% 19/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Asthenia	5.8% 9/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Fatigue	10.3% 16/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	9.2% 7/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Oedema peripheral	5.8% 9/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	2.6% 2/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
General disorders Pyrexia	2.6% 4/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	7.9% 6/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	9.6% 15/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	2.6% 2/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	3.8% 6/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	27.6% 21/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Amylase increased	5.8% 9/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	3.8% 6/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	21.1% 16/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Lipase increased	5.1% 8/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	6.6% 5/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Neutrophil count decreased	4.5% 7/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Platelet count decreased	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	3.8% 6/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	7.9% 6/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	1.3% 2/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 14/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	6.6% 5/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Dizziness	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	2.6% 2/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Headache	16.0% 25/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	13.2% 10/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Psychiatric disorders Insomnia	5.1% 8/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	1.3% 1/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.4% 10/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	5.3% 4/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dry skin	1.9% 3/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	7.9% 6/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	5.1% 8/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	6.6% 5/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	7.1% 11/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	22.4% 17/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Vascular disorders Hypertension	11.5% 18/156 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	3.9% 3/76 • For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days after study treatment discontinuation. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.

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